Description of Event or Problem · 1
NOVEMBER 18, 1992 AT 1200 PALL LEUKOPOOR BLOOD FILTER WAS USED PER POLICY AND PRIMED APPROPRIATELY BY RN. IMED PUMP IN USE WITH IV RUNNING. FILTER DIFFICULT TO PRIME AND BLOOD WOULD NOT INFUSE PROPERLY THROUGH IT. A SECOND PALL FILTER WAS OBTAINED AND PRIMED BY A DIFFERENT RN, AGAIN VERY SLUGGISH AND VERY TO INFUSE EVEN WITH IMED PUMP. THE IV RAN FREELY WITH SALINE AND IV REMAINED PATENT WITH EXCELLENT BLOOD RETURN. WHEN ATTEMPTING TO INFUSE BLOOD THE FILL CHAMBER WOULD COLLASPE IN ON ITSELF AND BLOOD COULD NOT BE PUMPED THROUGH THE FILTER WELL. ATHIRD PALL FILTER FUNCTIONED PROPERLY. THERE WAS NO PATIENT INJURYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.