Description of Event or Problem · 1
PT WAS A FORTY-FOUR-YR OLD, WHITE MALE, WITH HISTORY OF ITP FOR 6 MONTHS, POST-SPLENECTOMY AND FAILED IVIG THERAPY. HE ALSO HAD A HISTORY OF HODGKINS DISEASE. DURING PRESENT HOSPITALIZATION HE WAS INITIALLY ADMITTED FOR EVALUATION AND TREATMENT OF POSSIBLE ABDOMINAL BLEED AND SEPSIS. ATTENDING PHYSICIAN REQUESTED INITIATION OF IMMUNOABSORPTION THERAPY ON 11/28/94. CENTRAL LINE PLACEMENT WAS FIRST ATTEMPTED ON 11/28/94 WITHOUT SUCCESS, CAUSING DELAY IN TREATMENT SCHEDULE UNTIL 11/29/94. PT WAS NOT TAKING ANY ACE INHIBITORS. TREATMENTS ON 11/29/94 AND 12/1/94 WERE COMPLETED WITHOUT INCIDENTS. PT TOLERATED BOTH TREATMENTS WELL AND WAS STABLE THROUGHOUT. INITIALLY PLATELETS WERE IN THE RANGE OF 4,000 WITH COUNT UP TO 71,000 ON 12/1/94. PT WAS ALSO RECEIVING PLATELET TRANSFUSIONS DURING THIS HOSP STAY. HOWEVER, DUE TO NASAL SEPTAL BLEEDING, NASAL PACKING TWICE WAS NECESSARY. ON 12/3/94 TREATMENT WAS BEGUN AS USUAL. FLOOR RN INDICATED PT HAD BEEN MEDICATED WITH ORAL PAIN MEDICATIONS, M.S.WMGIV, AND ATIVAN PRIOR TO PROCEDURE. FIFTEEN MINS INTO PROCEDURE, PT BECAME DIAPHORETIC AND BP HAD DROPPED TO 83/46. AT THIS TIME PT ALSO HAD SMALL EMESIS OF DARK BLOOD AND COMPLAINED ABDOMINA PAIN. TREATMENT WAS STOPPED AND ATTENDING PHYSICIAN WAS NOTIFIED ALONG WITH MEDICAL DIRECTOR. RPTR WAS ADVISED TO DISCONTINUE TREATMENT IF SYSTOLIC BP WAS BELOW 100. DR ORDERED 0.9NS 500ML BOLUS TO BE GIVEN AND STAT CBC DRAWN. AFTER BOLUS GIVEN, DR WAS ADVISED OF BP 114/72; P117, R22. PROCEDURE WAS ORDERED TO RESUME. H&H REPORTED UNCHANGED FROM INIITAL AM VALUE ON 12/3/94. PROCEDURE WAS RESUMED BUT AT SLOWEST POSSIBLE RATE (PLASMA PUMP SET AT 10ML/MIN). PT'S BP AGAIN DROPPED BELOW 100 SYSTOLIC AND PROCEDURE WAS ABORTED WITH RINSEBACK COMPLETED (NOT VIA COLUMN). DOCTORS INFORMED OF TERMINATION OF PROCEDURE. FOLLOWING END OF PROCEDURE, PT WAS TRANSFERRED TO ICU; SCANS WERE TO BE PERFORMED. PT ARRESTED AND EXPIRED IN ICU AT 2242 (12/3/94). NO AUTOPSY WAS PERFORMED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.