BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEPARIN LCK FLSH FT 10 ML

    MDR report key: 2163565 · Received June 7, 2011

    Report

    Report Number
    1021343-2011-00002
    Event Type
    Other
    Date Received
    June 7, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 11, 2011
    Manufacturer
    HOSPIRA INC.
    Product Code
    NGT
    PMA / PMN Number
    K005264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT IDENTIFIED BY LOT NUMBER; THEREFORE, NO FURTHER INVESTIGATION COULD BE CONDUCTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DOCUMENT RECEIVED ALLEGED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THIS IS A COMBINATION PRODUCT THAT IS BEING REPORTED FOR THE DRUG PORTION OF THE PRODUCT. ON OR AROUND (B)(6) 2009, THE PT WAS ADMITTED TO THE HOSP FOR AN UNSPECIFIED DIAGNOSIS. IT WAS REPORTED THAT THE PT "WAS ADMINISTERED SEVERAL DOSES OF HEPARIN INCLUDING BUT NOT LIMITED TO, 5000 UNITS IV ON (B)(6), 2009; TWO HEPARIN INJECTIONS OF 5000 UNITS ON (B)(6), 2009; HEPARIN INFUSION OF 6500 UNITS IV PUSH AT 1000 UNITS/HR ON (B)(6), 2009; HEPARIN 5000 UNITS/500ML IV ON (B)(6), 2009; HEPARIN 6000 UNITS IV ON (B)(6), 2009; AND HEPARIN INFUSION AT 25,000 UNITS IN NORMAL SALINE (250ML) ON (B)(6), 2009 CONTINUING INTO (B)(6), 2009." ON OR AROUND (B)(6) 2009, THE PT "WAS DIAGNOSED WITH HEPARIN INDUCED THROMBOCYTOPENIA (HIT)." ALLEGEDLY THE PT "UNDERWENT A RIGHT ABOVE-THE-KNEE AMPUTATION OF HIS LEG." NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LCK FLSH FT 10 ML 80NGT NGT HOSPIRA INC. NA UNKDK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability HEPARIN 25,000 UNITS, MANUFACTURERS UNK| HEPARIN 6000 UNITS| HEPARIN 5000 UNITS| HEPARIN 6500 UNITS