BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-MS 3 AMBULATORY INFUSION PUMP

    MDR report key: 3143369 · Received May 24, 2013

    Report

    Report Number
    2183502-2013-00248
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    PMA / PMN Number
    K051568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THE PRODUCT WAS IN USE WITH A PT WHO HAS BEEN ON REMODULIN THERAPY SINCE (B)(6) 2010. ACCORDING TO REPORTER, THE PUMP ALARMED A FAILURE. THE PT COULD NOT SUCCESSFULLY RESTART HER PUMP. PER THE REPORTER, THE PT PRESENTED TO THE EMERGENCY ROOM FOR CONTINUATION OF HER INFUSION UNTIL A REPLACEMENT PUMP COULD BE SECURED. PT WAS WITHOUT REMODULIN FOR APPROX 6 HOURS TREATMENT WITH NO ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231561 CADD-MS 3 AMBULATORY INFUSION PUMP FRN - AMBULATORY INFUSION PUMP FRN SMITHS MEDICAL 21-7411 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention