BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP

    MDR report key: 10064170 · Received May 17, 2020

    Report

    Report Number
    3012307300-2020-04158
    Event Type
    Malfunction
    Date Received
    May 17, 2020
    Report Date
    May 17, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RETURNED DEVICE WAS RECEIVED WITH THE BOTTOM CASE CRACKED BY L-BRACKET.. EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE & REPAIR RECORDS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP, HAD A PRIMARY AUDIBLE ALARM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527767 SMITHS MEDICAL MEDFUSION 3500 SYRINGE PUMP PUMP, INFUSION. PRODUCT CODE: FRN FRN SMITHS MEDICAL ASD, INC. 3500-500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1