BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEPARIN 100U/ML

    MDR report key: 1011315 · Received March 7, 2008

    Report

    Report Number
    MW5005842
    Event Type
    Death
    Date Received
    March 7, 2008
    Date of Event
    January 5, 2008
    Report Date
    March 7, 2008
    Manufacturer
    AMSINO
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SAFETY EVALUATOR FOLLOW-UP REPORT. PT TERMS FROM ORIGINAL ISR: SUDDEN DEATH. CONTACT PROVIDING FOLLOW-UP INFO: DATE CONTACTED: 03/12/2008 VIA TELEPHONE. FOLLOW-UP INFO: LOT KH 02517 EXP 10/31/2008; KH 02552 EXP 10/31/2008 -100 U/ML HEPARIN LOCK FLUSH SOLUTION, USP 5 ML IN A 12 ML SYRINGE. REPORTER IS THE SISTER-IN-LAW OF THE PT AND IS A PHARMACIST. PT IS A FEMALE DIAGNOSED IN 2007 WITH BREAST CANCER. IN 2007, THE PT HAD A PICC LINE PLACED FOR CHEMOTHERAPY. PT WAS FLUSHING PICC LINE WITH 5 ML (500 UNITS) BID. PT HAD NOT RECEIVED ANY CHEMOTHERAPY PRIOR TO EVENT, BUT HAD EXPERIENCED N/V FOR A FEW DAYS REQUIRING BED REST. IN THE EVENING IN 2008, THE PT WAS IN UPSTAIRS BATHROOM PRESUMABLY DOING THE EVENING FLUSH WHEN HUSBAND HEARD HER FALL TO THE FLOOR. THE HUSBAND ATTEMPTED TO RESUSCITATE THE PT. SHE WAS TAKEN TO THE HOSPITAL AND PRONOUNCED DEAD. THE REPORTER STATES THAT THE HUSBAND DOES NOT RECALL A SYRINGE BEING IN THE PICC LINE OR ON THE FLOOR, BUT BELIEVES SHE WAS FLUSHING THE PICC AT THE TIME OF THE EVENT BECAUSE SHE HAD REMOVED HER SHIRT TO DO SO. AUTOPSY WAS PERFORMED BUT RESULTS HAVE NOT BEEN PROVIDED; PRELIMINARY FINDINGS SUGGEST THAT DEATH WAS NOT DUE TO PROGRESSION OF DISEASE AS "CANCER WAS NO SMALL AND CAUGHT RIGHT AWAY." ALTERNATE EXPLANATIONS FOR EVENT NOT YET PROVIDED. ALLERGIES: CIPRO (UNSPECIFIED). PMH: BACK PAIN/INJURY REQUIRING SURGERY APPROX 1 YEAR AGO. ATTACHMENT: NO.

    Description of Event or Problem · 1

    MS HAD A PIC LINE AND USED HEPARIN FLUSH TWICE A DAY. NDC FROM HEPARIN 68883-100-05. MS WAS NOT USING ANY OTHER MEDICATIONS VIA PIC LINE, MS DIED SUDDENLY IN 2008. AS OF DATE OF REPORT, STILL HAVE NOT RECEIVED OFFICIAL CAUSE OF DEATH FROM CORONER. DOSE OR AMOUNT: 500 UNITS. FREQUENCY: TWICE A DAY. ROUTE: INJ. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: FLUSH FOR PIC LINE.

    Description of Event or Problem · 1

    OFFICIAL CAUSE OF DEATH: COMPLICATION OF VIRAL RESPIRATORY ILLNESS (INFLUENZA). THERE WERE "CRYSTALS" FOUND IN PT'S LUNGS, THE CAUSE OR COMPOSITION WAS NOT EXPLAINED. HEPARIN FLUSHES WERE SUPPLIED BY A PHARMACY. PT HAD NOT UNDERGONE RECENT SURGERY AND HAD NOT REC'D RADIATION. THIS INCIDENT HAS NOT BEEN REPORTED TO FDA BY ANYONE ELSE; IT WAS RECENTLY REPORTED TO DEPT OF HEALTH.

    Description of Event or Problem · 1

    PT HAD A PIC LINE AND USED HEPARIN FLUSH TWICE A DAY. PT WAS NOT USING ANY OTHER MEDICATIONS VIA PIC LINE, PT DIED SUDDENLY IN 2008. THREE MONTHS LATER STILL HAVE NOT RECEIVED OFFICIAL CAUSE OF DEATH FROM CORONER. PT IS A FEMALE DIAGNOSED IN 2007 WITH BREAST CANCER. ON OR ABOUT 2007, THE PT HAD A PICC LINE PLACED FOR CHEMOTHERAPY. PT WAS FLUSHING PICC LINE WITH 5ML (500 UNITS) BID. PT HAD NOT RECEIVED ANY CHEMOTHERAPY PRIOR TO EVENT, BUT HAD EXPERIENCED N/V FOR A FEW DAYS REQUIRING BED REST. THE EVENING OF THE EVENT DAY, THE PT WAS IN UPSTAIRS BATHROOM PRESUMABLY DOING THE EVENING FLUSH WHEN HUSBAND HEARD HER FALL TO THE FLOOR. THE HUSBAND ATTEMPTED TO RESUSCITATE THE PT. SHE WAS TAKEN TO THE HOSPITAL AND PRONOUNCED DEAD. THE REPORTER STATES THAT THE HUSBAND DOES NOT RECALL A SYRINGE BEING IN THE PICC LINE OR ON THE FLOOR, BUT BELIEVES SHE WAS FLUSHING THE PICC AT THE TIME OF THE EVENT BECAUSE SHE HAD REMOVED HER SHIRT TO DO SO. AUTOPSY WAS PERFORMED BUT RESULTS HAVE NOT BEEN PROVIDED; PRELIMINARY FINDINGS SUGGEST THAT DEATH WAS NOT DUE TO PROGRESSION OF DISEASE AS "CANCER WAS SO SMALL AND CAUGHT RIGHT AWAY". ALTERNATE EXPLANATIONS FOR EVENT NOT YET PROVIDED. DOSE OR AMOUNT-500 UNITS, FREQUENCY-TWICE A DAY, ROUTE-INJ. DATES OF USE-2007 - 2008. DIAGNOSIS OR REASON-FLUSH FOR PIC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN 100U/ML NONE NZW AMSINO KH02517
    2 HEPARIN 100U/ML NONE NZW AMSINO KH02552

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death