Description of Event or Problem · 0
PT REPORTING CASSETTES LOT NUMBER 6022043 DEFECTIVE. EXPIRATION DATE IS UNKNOWN AS NOT REPORTED. 4 SEPARATE TIMES PUMPS ALARMED (PT SWITCHED OUT PUMPS) AND THEN REPLACED CASSETTE WITH DIFFERENT LOT NUMBER AND PUMP RAN FINE. PT HAS 6 OTHER CASSETTES OF THAT LOT NUMBER. CASSETTE WAS IN USE WHEN FAULT OCCURRED. NO LAPSE IN INFUSION OR SIDE EFFECTS/CLINICAL INJURY DUE TO MALFUNCTION. SENDING REPLACEMENT CASSETTES. PATIENT DOES HAVE BACK UP CASSETTES TO SWITCH TO AND WAS ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY. INFUSION IS LIFE-SUSTAINING AND CONTINUOUS. OUTCOME RESOLVED. NO ADDITIONAL INFO TO REPORT AT THIS TIME. CASSETTE RETURN TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES. DID THE REPORTED PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO, IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? N/A. IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? YES. DID WE REPLACE THE CASSETTE? YES. DID THE PATIENT HAVE ADDITIONAL CASSETTES THEY WERE ABLE TO SWITCH TO? YES, IF YES WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES, IF NO WHAT WAS THE PATIENT INSTRUCTED TO DO IN ABLE TO CONTINUE THEIR INFUSION? N/A. IS THE INFUSION LIFE-SUSTAINING? YES, WHAT IS THE OUTCOME OF THE EVENT ? RESOLVED? ON GOING? REPORTED TO (B)(6) BY PT/CAREGIVER.