Infusion Pumps

The firm identified customer sites where modules which the safety pacemaker label is missing. Information regarding the label included in the Operations Manual has been updated to specify: 1) the risk of malfunction applies to anyone with a pacemaker who may work on these modules; 2) the minimum safety distance has increased to 200 mm (7.87") from transport mechanisms. Any person with a pacemaker must not get closer than this distance from modules axes.

Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).

Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 will generate a negative result regardless of whether the patient was negative or positive for that antibody. This could result in a potential false negative result for that assay for any patients tested in well H6.

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.

Iincreased (falsely elevated) Albumin results compared to expected results

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient.

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.