Infusion Pumps

Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.

Tubing detachment

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.

The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.

Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury.

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.

Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.

Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.

NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.

Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.