Infusion Pumps

(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.

Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.

The devices have an incorrect firmware configuration.

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.

Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.

The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

Potential for intermittent lighting (flickering) during use.

An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.

It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.

Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.

Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.

The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.