AROUND THE MBI CIRCUIT
QUARTERLY SUMMARY: July - September 2006
A summary of FDA recalls, safety alerts, and manufacturer field corrective
actions as reported for the third quarter of the year. This information is
a snapshot and chronology of the reported events. For additional details refer
to the cited volume of original publication or contact the Home Office.
ABBOTT DIABETES CARE, INC. Glucose Meters: a)
FreeStyle Blood Glucose Meter; b) FreeStyle Flash Blood Glucose Meter. Class
II. Reason: The products may encounter display
problem, ‘Er 4’ message, during prolonged use when the low battery
symbol is displayed. Vol. 15:10.
ALCON LABORATORIES, INC. LADARVision Excimer Laser
System: CustomCornea software only. Class II. Reason: A
software error associated with the use of the Measuring Mode (ruler tool). Vol.
15:9.
BAYER HEALTHCARE. ADVIA 2120 Systems: Reason: The
ADVIA 2120 has reported highly intermittent low results on all primary results. Vol.
15:11.
BAYER HEALTHCARE. Automated Clinical Chemistry Analyzer:
a) ADVIA 1650 Chemistry System; b) ADVIA 1200 Chemistry System; c) ADVIA 2400
Chemistry System. Class II. Reason: Low QC recovery
observed immediately following certain assays. Vol. 15:11.
BAYER HEALTHCARE. RapidLab® 1200 Systems:
a) Model 1245-Blood gases, electrolyte and blood pH test system; b) Model 1265-Blood
gases, electrolyte and blood pH test system. Class II. Reason: Invalid
Co-Oximeter values. Vol. 15:11.
BECKMAN COULTER, INC. FP1000 Cell Preparation System: Software
version 1.0. Class II. Reason: During the
cleaning cycle performed during the shutdown procedure of the system, fluid
(diluted bleach) may drip from the probe in the location of the back reagent
rack potentially resulting in bleach and/or water dripping into the reagents
contaminating them and resulting in possible incorrect results. Vol.
15:12.
BECKMAN COULTER, INC. LH500 Hematology Analyzer:
all software versions. Class II. Reason: Beckman
has confirmed that erroneous results could be reported when the workstation
data base crashes. Vol. 15:10.
BECKMAN COULTER, INC. UniCel DxC 600/600PRO/600i/800/800PRO
Synchron Clinical Systems. Reason: Incorrect
Reagent Status. Vol. 15:11.
BIOMERIEUX, INC. OBSERVA R02: (version
R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected
to BacT/ALERT 3D. Class II. Reason: Software
problem with scanner inter-character delay which may result in false positive
or false negative results after incorrect scanning of bottle IDs. Vol.
15:9.
CARDINAL HEALTH, 303 INC., DBA Alaris Products, San Diego, California. Alaris ® SE
Pump (formerly Signature® Infusion Pump. Class I. Reason: This
recall was initiated because of a potential for over infusion with all models
of the Alaris® SE pumps caused by key bounce. Vol. 15:12.
DELPHI MEDICAL SYSTEMS. IVantage
Volumetric Ambulatory Infusion Pump/System. Class II. Florida. Reason: Potential
for under-infusion without alarm; cassette rollers stop moving, but the pump
shaft continues rotating without alarm. Vol. 15:11.
DISETRONIC MEDICAL SYSTEM. D-TRONplus Insulin Pump Battery
Pack. Class I. Reason: The battery may turn
the pump off without warning due to a design change in the battery. Vol.
15:12.
EDWARDS LIFESCIENCES. Edwards Vigilance Monitors: (Formerly
Baxter Vigilance Monitors). Reason: Edwards Lifesciences
Vigilance monitors with software release 5.3 or earlier may improperly cause
the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter
without alerting the user to this situation. This can result in overheating
and thermal damage to the CCO catheter and serious patient injury. Vol.
15:10.
GE HEALTHCARE. S/5 Anesthesia Delivery Unit, ADU.
Class II. Reason: There exists the possibility
that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling
of the anesthesia machine and result in no anesthetic agent output. Vol.
15:9.
GENERAL ELECTRIC MED. SYS. ULTRASOUND. Ultrasound: Voluson
730 Expert, Voluson 730 Pro, Voluson ProV with software versions 4.0.0., 4.0.1,
4.0.2., 4.0.3, 4.0.4., 4.0.5, 5.0.0, 5.0.1. Class III. Reason: In
the cardiac measurement section of the device, the calculation of the PF Mean
(mean pressure gradient) leads to an erroneous result. Vol.
15:9.
HAMILTON MEDICAL, INC. Ventilators: a) RAPHAEL
Ventilator, software version 2.2x; b) RAPHAEL Silver Ventilator, software version
2.2xS; c) RAPHAEL Color, software version 2.2xC, 2.2xCU. Class II. Reason: Alarm
Failure – Following an oxygen cell calibration, the user may inadvertently
and unknowingly disable the alarm system. Vol. 15:10.
INO THERAPEUTICS, INC. INOvent,
Nitric Oxide Delivery System. Class II. Reason: The
Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in
the INOmax valve outlet. Vol. 15:11.
INVACARE CORPORATION. Manual Wheelchair, Kuschall’s
K3/K4 series: Model Airlite. Class II. Reason: If
the users have chosen to install optional anti-tippers on the chair, the
anti-tipper as designed may not be able to bear the stress of repeated or
quick loads placed on it, causing the bolt to bend or break. Vol.
15:12.
KIMBERLY-CLARK CORPORATION. Electrodes. Class
II. Reason: The tinfoil in the triangle electrodes
has the potential to develop cracks, which may hinder electrical flow and product
performance during defibrillation. Vol. 15:10.
LEICA MICROSYSTEMS. Surgical Microscope: Leica
M520. Class II. Reason: Patient Burns – The
use of the surgical microscope at high light intensity and short working distances
can result in patient burns. Vol. 15:9.
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. Defibrillator:
LIFEPAK 20 External defibrillator/monitor. Class II. Reason: Devices
with V38 system software do not display a “LOW BATTERY: CONNECT TO
AC POWER” message when the monitor is on backup (DC) battery power
and may shut down without warning. Vol. 15:12.
MRL, INC. (Welch Allyn). PIC50 Automatic
External Monitors/Defibrillators. Class I. Reason: A DEFIB
COMM ERROR, which may prevent or unacceptably delay the delivery of therapy,
which may fail to resuscitate the patient. This problem occurs because of
an intermittent electrical connection within the device. Vol. 15:9.
PHILIPS MEDICAL SYSTEMS, NORTH AMERICA. Easy Vision Workstation
Family. PACS EasyVision / EasyAccess Release 10.1/10.2 Class
II. Reason: Potential for measurements, lines,
texts, etc to be stored incorrectly. Any added arrow will point to the wrong
anatomical structure and will make the image useless in combination with
reported findings. Vol. 15:10.
PHILIPS MEDICAL SYSTEMS, NORTH AMERICA. IntelliVue MultiMeasurement
Server. (MMS), physiological patient monitoring system; Model
M3001A. Class II. Reason: Patient monitor
may display inaccurate reading when the disposable SpO2 sensor is not attached. Vol.
15:12.
PHILIPS MEDICAL SYSTEMS, NORTH AMERICA. X-Ray System: a)
MD3 X-Ray System; b) MD4 X-Ray System. Class II. Reason: Potential
for unexpected table movement. Vol. 15:10.
RADIOMETER AMERICA, INC. Analyzers: a)
Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 Series
; b) Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-800 Series. Class
II. Reason: The ABL 700 & 800 Series
Blood Gas Analyzers may experience leakage current into the measuring system.
Consequently, the analyzers intermittently provide incorrect (too low) result
values for Calcium (Ca) and Sodium (Na). Vol. 15:10.
RADIOMETER AMERICA, INC. D826 Accessory Kit: for single
TCPO2 Electrodes for use with the TCM400 Transcutaneous Monitor, Model #D826. Class
II. Reason: Excessive Drift – the
membrane units of the device cause the electrode to exceed performance standards
for drift in the first two or more calibrations. Vol. 15:12.
RADIOMETER AMERICA, INC. TCM4 Series Monitoring System:
(Base Unit) Model: 391-876 transcutaneous oxygen monitor; Compact Flash cards – Model
# 914-698. Class III. Reason: System
shut down – When the TCM Monitor is turned on and the booting process
begins, the device stops after the memory count and will not proceed further. Vol.
15:12.
RESPIRONICS, INC. NeoPAP Neonatal CPAP/Humidification
System (Ventilator, Continuous). Class II. Reason: Gas
input pressures over 62 psi may cause CPAP pressure oscillation. Vol.
15:9.
RIVERAIN MEDICAL GROUP. Medical Image Analyzer: a)
RapidScreen RS-2000; b) RapidScreen RS-Digital. Class III. Reason: The
device has an actual sensitivity of 58.2% and a specificity of 3.9% (false
positives per image). The product is approved to have a sensitivity of 63.3%
and a specificity of 5.0, resulting in a difference of -5.1% in sensitivity
and +1.1 in specificity. Vol. 15:9.
ROCHE DIAGNOSTICS CORP. ACCU-CHEK
Advantage Blood Glucose Meters: Class II. Reason: The
meter (s) gives an error message that can actually mean either a problem
with the strip or a blood glucose too low to measure, but the meter error
message only reports that the test strip may be damaged or test was not performed
correctly. Vol. 15:10.
ROCHE DIAGNOSTICS CORP. ACCU-CHEK
Test Strips: Class II. Reason: The
drying agent beads, located in the cap, may become loose and fall into the
vial. causing the test strips to potentially give incorrect blood glucose
test results. Vol. 15:10.
ROCHE DIAGNOSTICS CORP. LC Systems: Class
II. Firm initiated recall ongoing. Firm notified users by letter on July
17, 2006. Reason: If the user opens the
instrument lid during decontamination, the cycle will stop, but the timer will
continue resulting in the user believing the instrument has been decontaminated
when it has not. Vol. 15:10.
ROCHE DIAGNOSTICS CORP. Roche/Hitachi K Electrode. Reason: A
design change in the electrodes will result in incorrect potassium level results. Vol.
15:10.
ROCHE DIAGNOSTICS CORP. Roche/Hitachi
K Electrode. Class III. . Reason: Expired
product (dated 2006.06) was shipped as replacement for recalled product. Vol.
15:11.
SAMMONS PRESTON ROLYAN. Tables: a) ValueLine Mat Platform;
b) Midland Deluxe Mat Platform; c) Midland Deluxe Mat Platform with Adjustable
Backrest; Midland Space-Saver Mat Platform; ValueLine Space-Saver Folding Mat
Platform.. Class II. Reason: Reports of
structural failure on the skirt of select tables. The risk to patients presented
by possible structural failure of the skirt of the table is a slow collapse
of the plinth which could cause the patient to be displaced. Vol.
15:9.
SIEMENS MEDICAL SOLUTIONS USA, INC. KinetDx 4.0 Ultrasound
Image Management System. Class III. Reason: The
cardiologist’s report comments may not be retained due to a software
bug. Vol. 15:10.
SIEMENS MEDICAL SOLUTIONS USA, INC. 3D-I/III Ceiling
Stand: Diagnostic x-ray tube mount. Class II. Reason: Firm
became aware that a potential pinch point can exist between the stop level
and the safety catch when rotating the x-ray tube assembly. Risk of injury
to operators’ fingers. Vol. 15:9.
SKYTRON, DIVISION, The KMW GROUP, INC. Surgical
Tables. Class II. Reason: The
release levers can inadvertently release under load while the leg section
is positioned at a ninety degree angle causing the leg section to drop. Vol.
15:12.
SPACELABS MEDICAL INCORPORATED. Medical 1400 MHz
Telemetry System. Class II. Reason: Potential
for patient waveforms to move to an open receiver module or to an occupied
receiver causing the intermittent inappropriate monitoring of both patients
for several minutes. Vol. 15:9.
STERIS CORPORATION. Sonic Cleaner. Class
II. Reason: Smoke, sparking, and fire
hazard. Vol. 15:11.
STRYKER MEDICAL DIVISION OF STRYKER CORPORATION. Trio
Mobile Surgery Platform: Model Class II. Reason: An
incorrect pin may have been used during assembly and therefore the device
may give way during use. Vol. 15:9.
TELEFLEX MEDICAL. Green Spec Fiberoptic Laryngoscope Handle: --Stubby/Short. Class
II. Reason: Teleflex Medical has identified that
the product may malfunction, causing the handle to heat up. There is a potential
for the heated handle to burn the user. Vol. 15:10.
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION. Advanced
Perfusion System 1. Class II. Reason: The
manual roller pump speed control may fail to function/change pump speed. Vol.
15:11.
VARIAN MEDICAL SYSTEMS, INC. Clinac C-series Pendant
Radiation Delivery System: All models. Class II. Reason: Machine
may produce unexpected motions from the couch, collimator, and gantry rotation
at maximum speeds. Vol. 15:9.
VARIAN MEDICAL SYSTEMS. Software: a) GammaMed
software program for the GammaMed model 12i radionuclide applicator system;
b) GammaMed software program for the GammaMed model 12it radionuclide
applicator system. Class II. Reason: Software
control program for a medical device used in radiation treatment may cause
practitioners to incorrectly administer the treatment plan to cancer patients. Vol.
15:10.
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS. Varis
Vision Treatment 6.6/RTP Exchange/Siemens Accelerators. Class
II. Reason: A software anomaly may occur which can
lead to patient treatment with the wrong field. The anomaly is reported only
to occur when this software version (6.6.5022) is used with Elekta or Siemens
linear accelerators. Vol. 15:10.
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