BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETELY PROGRAMMABLE PUMP W/LUER-LOCK TUBING

    MDR report key: 1860241 · Received September 21, 2010

    Report

    Report Number
    2648666-2010-00404
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FRN
    PMA / PMN Number
    K042405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A POST-OPERATIVE PAINPUMP. THE PT REPORTED THAT THE PUMP RAN OUT OF MEDICATION AFTER ONLY 19 HOURS OF USE, BUT CONTINUED PUMPING. THE PT RETURNED TO THE HOSP WHERE HE RECEIVED A BOLUS OF MEDICATION, AND A NEW PAINPUMP WAS GIVEN FOR PAIN RELIEF. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETELY PROGRAMMABLE PUMP W/LUER-LOCK TUBING INFUSION PUMP FRN STRYKER INSTRUMENTS PUERTO RICO 10165022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK