CENTRYSYSTEM BLOOD TUBING

Description of Event or Problem

DURING DIALYSIS TREATMENT, THE PUMP SEGMENT OF THE BLOOD LINES SEPARATED FROM THE MAIN SECTION OF THE ARTERIAL BLOOD TUBING. ESTIMATED BLOOD LOSS ON THE FLOOR WAS 75 TO 100 MLS. THE LINES WERE CLAMPED BY THE STAFF PREVENTING FURTHER LOSS OF BLOOD. HOWEVER, THEY WERE UNABLE TO RETURN THE BLOOD IN THE REMAINDER OF THE EXTRACORPOREAL CIRCUIT LEADING TO AN ADDITIONAL LOSS OF 200 - 250 MLS OF BLOOD. THE PATIENT WAS DISCHARGED HOME AND DID NOT REQUIRE A BLOOD TRANSFUSIONDEVICE 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, NONE OR UNKNOWN. 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 RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.