BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+3 PUMP MEDNET WIRELESS

    MDR report key: 1012345 · Received February 12, 2008

    Report

    Report Number
    2921482-2008-00084
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 21, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER HEPARIN (25000UNITS/500ML), WITH A DOSE OF 80UNITS/KG/HR INSTEAD OF THE INTENDED DOSE OF 15 UNITS/KG/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE PROGRAMMING ERROR. THE PHYSICIAN WAS NOTIFIED AND THE DELIVERY WAS STOPPED. A PARTIAL THROMBOPLASTIN TIME (PTT) WAS DRAWN AND FOUND TO BE "VERY HIGH." A CT SCAN OF THE HEAD WAS ORDERED. AFTER APPROXIMATELY 3 TO 4 HOURS, A REPEAT PTT WAS DRAWN AND THE RESULTS REPORTEDLY REMAINED "HIGH." THE PATIENT WAS TREATED WITH TWO DOSES OF PROTAMINE SULFATE (250MG/25ML). AFTER AN UNSPECIFIED LENGTH OF TIME, THE PTT VALUE WAS REPORTED AS "LESS THAN THERAPEUTIC" AND THE DELIVERY OF THE HEPARIN WAS RESTARTED AT A DOSE OF 15 UNITS/KG/HR. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 PUMP MEDNET WIRELESS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R HEPARIN