HEPARIN

Description of Event or Problem

FACILITY REPORTS THAT FIVE DIALYZERS CLOTTED. CHLORINE CHLORAMINE WNL. WATER HARADNESS WITH NORMAL LEVEL. FACILITY SUSPECTS PROBLEM IS WITH HEPARIN. FACILITY USED NEW LOT OF HEPARIN AND ALL TREATMENTS RE-INITIATED WITHOUT PROBLEMS. THERE WAS NO PATIENT MEDICAL INTERVENTION. EBL 300CC'S AS REPORTED BY HCP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.