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November 2011 - vol. 20:14

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

FDA Med Watch

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation. FDA notified healthcare professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient. CareFusion contacted customers in September 12th, 2011 stating the identified potential risks associated with the EnVe ventilators. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. Carefusion is contacting facilities to coordinate hardware and software updates for affected ventilators. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Mizuho OSI Modular Table Systems – Class I Recall – Reports of Patient Injury - FDA notified health professionals of a Class I Recall of Mizuho OSI Modular Table Systems because of reports of patient injury related incidents. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Patient falls or unanticipated movement may result in serious injury or death. On July 29, 2011, Mizuho issued a Field Advisory Notice to Hospital Risk Management, Operating Room Directors, Operating Room Technicians, Physicians, Nurses, Anesthesiologists and any personnel involved in the use and/or set up of the OSI Modular Table Systems. The Field Advisory Notice provided warnings and recommendations for safe use of the Mizuho OSI Modular Table Systems including performing a verification count of all the T-pins to confirm the stability of the table top.

B BRAUN MEDICAL INC., Carrollton, TX. Outlook ES Safety Infusion System. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 8th, 2011. Volume in Commerce: 11,525 pumps. Reason: The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD – HOLD key strokes are performed on the pump key panel. FDA recall #Z-0007-2012. FDA Enforcement Report, 10/26/11.

BOSTON SCIENTIFIC CRM CORP., Saint Paul, MN. Manufacturers: Benchmark Electronics Inc., Winona, MN. Latitude Patient Management System Communicator. Class II. Firm initiated recall ongoing. Firm notified users by telephone on May 25th, 2011. Volume in Commerce: 2 units. Reason: Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted on the website. No patient deaths or injuries have been associated with this communicator behavior. FDA recall #Z-3183-2011. FDA Enforcement Report, 11/2/11.

IMPAC MEDICAL SYSTEMS INC., Sunnyvale, CA. Impac Medical Systems Sequencer Product Usage. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 20th, 2011. Volume in Commerce: 11 devices. Reason: Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq. FDA recall #Z-0052-2012. FDA Enforcement Report, 10/26/11.

INVIVO CORP. Orlando, FL. MRI Patient Monitoring System. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 9th, 2011. Volume in Commerce: 285 units. Reason: During transport of the system’s cart with a docked Display Controller Unit , a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall. FDA recall #Z-0106-2012. FDA Enforcement Report, 11/2/11.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Gmbh, DMC, Development & Manufacturing Ctr., Hamburg, Germany. PCR Eleva Radiological Image Processing System. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 10th, 2011. Volume in Commerce: 197 units. Reason: The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored again within a PACS system. This could potentially lead to a misdiagnosis. FDA recall #Z-3205-2011. FDA Enforcement Report, 10/26/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Harbor, MI. CDI Blood Parameter Monitoring System 500. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 23rd, 2011. Volume in Commerce: 432 units. Reason: Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery are restored. FDA recall #Z-0142-2012. FDA Enforcement Report, 11/9/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ashland, MA. Manufacturer: Alliant Enterprises LLC, Richmond, MI. Cardiovascular Custom Procedure Kits. Class II. Firm initiated recall ongoing. Firm notified users by telephone, fax, email and letter on August 12th, 2011. Volume in Commerce: 4,114 kits. Reason: 3-T Medical Systems one way vent valves, included in the Custom Cardiovascular kits, may separate at the bond that holds the two halves. FDA recall #Z-3222/3252-2011. FDA Enforcement Report. 10/26/11.