IPS PRESSURE SENSOR CONNECTING CABLE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3, H6 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. ONE SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS SERIAL NUMBER. THE PRODUCT WAS NOT RETURNED, AND A PHYSICAL INVESTIGATION COULD NOT BE CARRIED OUT. A DEFECT IN THE CABLE OR CABLE CONNECTION MAY HAVE CAUSED THE ISSUE, HOWEVER, A DEFINITIVE CAUSE FOR THE DEFECT COULD NOT BE DETERMINED. THE PROBLEM DESCRIBED IS POTENTIALLY ATTRIBUTED TO A KNOWN ISSUE. THE PLUG CONNECTION TO THE SENSOR MUST HAVE A TIGHT FIT TO ENSURE THAT IT IS WATERTIGHT. HOWEVER, THE DESIGN OF THE CABLE AND THE RESULTING MANUFACTURING PROCESS MAKES THE CABLE SUSCEPTIBLE TO DAMAGE DURING USE (BREAKING OR TEARING OUT OF THE COMPONENTS). THE COMPONENT IS A PURCHASED PART. THE ISSUE HAS BEEN FORWARDED TO RESEARCH AND DEVELOPMENT TO REVIEW THE DESIGN FOR IMPROVEMENT.

Description of Event or Problem

A USER FACILITY REPORTED WHEN A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT UTILIZING PUMP #1, THE USER FOUND ONE OF THE PRESSURE CABLES WAS NOT READING. THE USER HAD A REPLACEMENT PRESSURE CABLE AND THEY WERE ABLE TO SWAP IT OUT WHICH RESOLVED THE ISSUE. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION; HOWEVER, THE COMPLAINT SAMPLE WAS NOT RECEIVED.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY REPORTED WHEN A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT UTILIZING PUMP #1, THE USER FOUND ONE OF THE PRESSURE CABLES WAS NOT READING. THE USER HAD A REPLACEMENT PRESSURE CABLE AND THEY WERE ABLE TO SWAP IT OUT WHICH RESOLVED THE ISSUE. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.