BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION SYRINGE PUMP

    MDR report key: 10096019 · Received May 28, 2020

    Report

    Report Number
    3012307300-2020-05182
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Report Date
    August 4, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    REPAIR NOTES FROM WORK COMPLETED BY A SMITHS MEDICAL FIELD SERVICE TECHNICIAN AT THE CUSTOMER FACILITY: FIRMWARE VERSION: SOURCE: 011061058604356711170123212029720 V.1.6.1 IS THERE AN ALARM CONDITION N/A INITIAL BATTERY CHARGE LEVEL: 99% STARTING WIRELESS COMMUNICATION MAC ADDRESS: 00:22:88:01:1D:3F DUPLICATE MAC ADDRESS (CROSS REFERENCE PROVIDED LIST: N0 NEW WIRELESS COMMIUNICATION MAC ADDRESS (IF DUPLICATE):N/A ORIGINAL BATTERY LOT#: MN150816 NEW BATTERY LOT#: MN130520 POWER CORD RETAINER UPON RECEIPT: YES VERIFY SWITCH FROM "AC CONNECTED" TO FLASHING "BATTERY" LED AFTER DISCONNECTING FROM AC POWER SOURCE Y/N: YES CONDITION OF SMITHS SEAL IN BATTERY COMPARTMENT (FACTORY, REPLACED OR MISSING): MISSING OBSERVATIONS OF INITIAL CONDITION J9 CONNECTOR (STEP 2G IN PAA PROCEDURE): NOT CORRECT PER PAA PROCEDURE OBSERVATIONS OF J9 CONNECTORS AFTER DISCONNECTING AND REMOVING GLUE BEAD. NOTE ANY CONNECTOR DAMAGE, DISTORTIONS, FOREIGN MATERIALS, ETC. (STEP 2L IN PAA PROCEDURES): GOOD REASSEMBLED AND INSPECTED THE MATING OF THE RIBBON CABLE CONNECTOR AND J9 OF THE MAIN PCBA TO VERIFY CONNECTORS ARE FULLY SEATED. (STEP 3C IN PAA PROCEDURE) COMPLETED OR N/A: GLUE WAS INSTALLED PER PAA PROCEDURE QUICK CHECK PERFORMED AFTER RE-ASSEMBLY WITHOUT ISSUE: YES PUMP CONNECTED TO SERVER POST PROCEDURE: YES POWER CORD RETAINER ATTACHED POST PROCEDURE: YES DEVICE COMPLETION DATE: (B)(6)2020.

    Description of Event or Problem · 0

    REPAIR NOTES FROM WORK COMPLETED BY A SMITHS MEDICAL FIELD SERVICE TECHNICIAN AT THE CUSTOMER FACILITY AS PUMP WAS NOT RETURNED . SUMMARY IN H -10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE A PRIMARY AUDIBLE ALARM BGND MESSAGE. THE REPORTER DID NOT CONFIRM WHETHER THE ISSUE OCCURRED AFTER POWER ON OR DURING PATIENT INFUSION. NO ADVERSE EFFECTS TO PATIENT REPORTED. FIELD SERVICE EXAMINATION OF THE DEVICE SHOWED PRIMARY AUDIBLE ALARM BGND OCCURRED IN ALARM HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562724 MEDFUSION SYRINGE PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1