BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEPARIN FLUSH

    MDR report key: 1031487 · Received April 16, 2008

    Report

    Report Number
    MW5006288
    Event Type
    Death
    Date Received
    April 16, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 16, 2008
    Manufacturer
    MEDEFIL
    Product Code
    NZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING HOME INTRAVENOUS ANTIBIOTIC THERAPY THROUGH PICC LINE. WIFE WAS FLUSHING LINE, AS SHOWN BY HOME CARE NURSE. PT WAS PRESCRIBED HEPARIN FLUSH 300 UNITS/3ML SYRINGES FOR FLUSH. PT RECEIVED MEDEFIL INC HEPARIN FLUSH SYRINGES, LOT # H108106, QUANTITY 6 SYRINGES IN 2008. PT RECEIVED 15 SYRINGES ONE DAY LATER, SAME LOT NUMBER. PT RECEIVED 16 SYRINGES SEVEN DAYS LATER, SAME LOT NUMBER. HOME INFUSION COMPANY ARRIVED AT PT'S HOME THREE DAYS LATER, TO RETRIEVE PROD DUE TO A MFR'S RECALL NOTICE. WIFE INDICATED THAT SHE USED THAT PROD AS PRESCRIBED DURING TIME FRAME PRIOR TO FIRST RECEIVED UNTIL THE FOLLOWING TWELVE DAYS. PT WAS RECEIVING ZOSYN IVPB Q12HRS FOR POST OPERATIVE PARTIAL AMPUTATION OF RIGHT FOOT. PT ADMITTED TO HOSP THE NEXT MONTH, AFEBRILE, CHIEF COMPLAINT OF FEVER AND CHILLS FOR PAST 24 HRS. UPON ADMISSION, PT TOTAL WHITE BLOOD CELL COUNT OF 2500, ABSOLUTE NEUTROPHIL COUNT OF 1600. PT RAPIDLY DECOMPENSATED, REQUIRING INTUBATION FOR MECHANICAL VENTILATION ON THE SAME DAY. PT WENT INTO MULTIPLE ORGAN DYSFUNCTION TWO DAYS LATER WITH ACUTE RENAL FAILURE, LIVER FAILURE, RHABDOMYOLYSIS, REQUIRING VASOPRESSOR SUPPORT TO SUSTAIN BLOOD PRESSURE. PT WAS NOT ABLE TO BE WEANED OFF MECHANICAL VENTILATION SUPPORT PT EXPIRED SEVEN DAYS LATER. DIAGNOSIS OR REASON FOR USE: PICC LINE FLUSH.

    Description of Event or Problem · 1

    RESPONSE TO FDA INQUIRY: THE PT WAS RECEIVING ZOSYN IVPB EVERY 12 HRS THROUGH PICC LINE AT HOME FOR POST SURGICAL PARTIAL AMPUTATION OF RIGHT FOOT. PT PRESENTED TO THE HOSPITAL AND MEDICAL CENTER WITH TEMP 102 AND RIGORS. TRANSFERRED TO EMERGENCY DEPT IN 2008 AT 22:10. TEMP 98.4, PULSE 73, RR 16, BP 109/65 AT TIME OF E.D. TRIAGE. CHIEF COMPLAINT FEVER, CHILLS FOR THE PAST 12 HRS. PMH INCLUDES CHF, CAD, HYPERTENSION, HIGH CHOLESTEROL, PVD, AND PENILE CANCER. PT WAS ADMITTED, SEPSIS WAS SUSPECTED. PT WAS ON A VENTILATOR AND BEING AGGRESSIVELY TREATED, BUT HIS CONDITION CONTINUED TO WORSEN. FAMILY INFORMED OF GRAVE PROGNOSIS, AND AGREED TO TERMINAL WEAN OF THE VENTILATOR. PT EXPIRED TEN DAYS LATER AT 7:14 A.M. THE PT'S BODY WAS RELEASED TO THE FUNERAL HOME. IT IS UNLIKELY AN AUTOPSY WAS PERFORMED. THE PT NEVER RECEIVED HEPARIN WHILE AT MEDICAL CENTER. THE PT REC'D THE HEPARIN FROM THE HOME INFUSION CO., COMPLETE INFUSION SERVICES. THE CONTAMINATED HEPARIN WAS PICKED UP FROM THE PT'S HOME BY COMPLETE INFUSION SERVICES ON THE PREVIOUS MONTH. SINCE THE PT NEVER REC'D THE HEPARIN AT THE HOSP, THE HEPARIN WAS REC'D FROM COMPLETE INFUSION SERVICES, SUGGEST F/U WITH COMPLETE INFUSION SERVICES REGARDING THIS QUESTION. THE FACILITY DID NOT EXPERIENCE SIMILAR EVENTS. THE FACILITY HAS NOT DISCUSSED THIS EVENT WITH THE MFR SINCE THE HEPARIN WAS NOT ADMINISTERED HERE. THE CONTAMINATION EVENT DID NOT OCCUR AT THE HOSP, SO THERE WAS NO NEED FOR AN ACTION PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN FLUSH 300 MG / 3ML NZW MEDEFIL H108106

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| L SODIUM CHLORIDE 10 ML PREFILLED SYRINGES| INFO FROM HOME INFUSION PRECRIPTION.| 100 ML| ZOSYN 3.375 GM IN 0.9% SODIUM CHLORIDE