BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ PLANTINUM MOD

    MDR report key: 1622259 · Received March 2, 2010

    Report

    Report Number
    2921482-2010-00098
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    December 25, 2009
    Report Date
    February 2, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. THE PATIENT WAS BEING TREATED IN THE INTERMEDIATE CARE UNIT FOR A DIAGNOSIS OF PAROXYSMAL SUPRA-VENTRICULAR TACHYCARDIA, CORONARY ARTERY DISEASE AND HYPERTENSION. ON (B) (6) 2009 AT 2345, THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN 25,000 UNITS/250ML, WITH A DOSE OF 1000 UNITS/HR, AND A VTBI (VOLUME TO BE INFUSED) OF 200ML, AT A CALCULATED RATE OF 10ML/HR AND THE DELIVERY WAS STARTED. ON (B) (6) 2009 AT 0230, THE DEVICE SOUNDED AN UNSPECIFIED ALARM. AT THIS TIME, THE NURSE NOTED THE HEPARIN CONTAINER WAS EMPTY. THE PHYSICIAN WAS NOTIFIED AND ORDERED A PTT (PARTIAL THROMBOPLASTIN TIME) LEVEL BE DRAWN. THE RESULT WAS REPORTED AS >200 SECONDS. THE HEPARIN THERAPY WAS DISCONTINUED. NO FURTHER TREATMENT WAS REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AT 2305, THE HEPARIN THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE PATIENT WAS DISCHARGED ON (B) (6) 2009. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ PLANTINUM MOD 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention HEPARIN, LIST 07793, LOT UNK, MFR BY HOSPIRA, INC| PLUM A+ SOFTWARE MODULE, LIST #12097, SN UNK