Description of Event or Problem · 1
1/94 THROUGH 5/94, 120 QUALITY CONTROL SAMPLES FROM CO'S FILTERED RED BLOOD CELLS WERE SUBMITTED FOR QUALITY CONTROL TESTING. ONE FAILURE WAS NOTED AND ATTRIBUTED TO POOR TECHNIQUE AS THIS SAMPLE WAS SUBMITTED FOR QUALIFYING A NEW EMPLOYEE TO PERFORM THE FILTRATION. THE EMPLOYEE WAS RETRAINED, FOUR ADD'L SAMPLES WERE SUBMITTED AND PASSED. ON 9/12/94 A FULL INVESTIGATION AND COMPREHENSIVE REVIEW OF ALL LEUKO REDUCTION QUALITY CONTROL RESULTS WAS INITIATED BY CENTRAL OFFICE. IN ORDER TO ASSURE COUNTING TECHNIQUE WAS ACCURATE 2 SEPARATE INITIATIVES WERE TAKEN. IN ADDITION, THE WBC COUNTS FROM ALL LEUKO REDUCED COMPONENT QUALITY CONTROL WAS REVIEWED FOR STATISTICAL ANALYSIS. OTHER MEANS OF FILTRATION FOR LEUKO REDUCED RED BLOOD CELLS WERE INSTITUTED UNTIL THE CAUSE OF THE QUALITY CONTROL FAILURES COULD BE IDENTIFIED AND RESOLVED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MODIFICATION OF DEVICE. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.