Description of Event or Problem · 1
THE PATIENT HAD BEEN ON DIALYSIS FOR 5 MINUTES, WHEN THE DIALYZER CRACKED OPEN AT THE SIDE SEAM. THE NEEDLES AND LINES WERE IMMEDIATELY CLAMPED OFF AND THE ONLY RESULTING BLOOD LOSS WAS THE AMOUNT IN THE DIALYZER AND BLOOD LINES THEMSELVES, APPROXIMATELY 250 - 300MLS. THE PATIENTS PRE DIALYSIS HEMATOCRIT HAD BEEN 30%. THE PATIENT WAS STABLE POST INCIDENT AND DID NOT REQUIRE TRANSFUSION. THE DIALYZER HAD PASSED ALL THE MANUFACTURERS SUGGESTED ALARM AND PRESSURE TESTING.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING, TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.