Description of Event or Problem · 1
DURING THE ERAPEUTIC PLASMA EXCHANGE, THE PATIENT RECEIVED 3 L OF ALBUMIN WITHOUT PLASMA BEING REMOVED DUE TO FAILURE OF A VALVE TO OPEN. THE PLASMA COLLECTION VALVE WAS FOUND TO HAVE BUILT UP AND DID NOT FUNCTION PROPERLY. THIS PROBLEM COULD BE REPLICATED DURING TESTING. IT SHOULD BE NOTED THE REPRESENTATIVE FAILED TO DETECT PLASMA BUILDUP DURING HIS ROUTINE INSPECTION. HE INDICATED THAT WHILE SOFTWARE CURRENTLY DOES NOT MONITOR VALVE POSITION. FUTURE MODIFICATIONS ARE PLANNED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPUTER SOFTWARE PROBLEM, FOREIGN MATERIAL CONTAMINATION, VALVE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.