Description of Event or Problem · 1
ON OCTOBER 25, 1993 A 76 YEAR OLD FEMALE WITH RUPTURED ABDOMINAL AORTIC ANEURYSM WAS ADMITTED TO EMERGENCY DEPARTMENT. THE PHYSICIAN ORDERED TWO O NEGATIVE UNCROSSMATCHED RED BLOOD CELL UNITS TO BE ADMINISTERED IMMEDIATELY. THE PATIENT WAS TAKEN TO THE SURGERY DEPARTEMENT AND ALL AVAILABLE O NEGATIVE UNITS OF RED BLOOD CELLS WERE ISSUED FOLLOWED BY O POSITIVE UNITS.UPON COMPLETION OF TESTING THE PATIENT WAS DETERMINED TO BE ONEGATIVE WITH ANTI-D AND ANTI-C ANTIBODIES IN HER SERUM. SEVEN OF THE SEVENTEEN UNITS OF RED BLOOD CELLS INFUSED WERE O POSITIVE, FIVE OF THE UNITS WERE C POSITIVE.THE ORIGINAL BLOOD SPECIMEN HAD A NEGATIVE DIRECT ANTIGLOBULIN TEST, A TOTAL BILIRUBIN OF 0.5 MG/DL AND A BUN OF 17 MG/DL. A BLOOD SPECIMEN COLLECTED AT 9750 ON 10/25/93 DEMONSTRATED A POSITIVE DIRECT ANTIGLOBULIN TEST. POSTOPERTIVELY THE PATIENT DEVELOPED ADULT RESPIRATORY DISTRESS SYNDROME. THE PATIENT RECEIVED SEVEN ADDITIONAL UNITS OF RED BLOOD CELLS DURING HER HOSPITAL STAY, ALL OF THESE WERE O NEGATIVE, C NEGATIVE. A BLOOD SPECIMEN COLLECTON ON 11/11/93 WAS RESULTED WITH A TOTAL BILIRUBIN OF 38.2 MG/DL AND A BUN OF 121 MG/DL. THERE WAS NO EVIDENCE OF INTRAVASCULAR HEMOLYSIS.THE PATIENT EXPIRED ON NOVEMBER 11, 1993 AT 1820. THE CAUSE OF DEATH WAS LISTED AS: 1) RESPIRATORY FAILURE, 2) HEMOLOYSIS AND 3) RUPTURED ABDOMINAL AORTIC ANEURYSM.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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.