Infusion Pumps

Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.

The product lot did not meet sterility requirements based on FDA sampling and analysis.

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.

If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?.¿ The difference in terminology exists for US Markets only.

Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.

Software error in previous software versions in which two references for the same image may exist in the database.

Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.

Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

Demonstrate an upward shift in patient results.

Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.

Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.

The pouch label was missing the use by date (UBD) of 2018-04.

Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead

The device was found to have bacterial contamination.

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).

The device is reported to enter safe mode and is no longer able to charge batteries.