BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSYTEM III INFUSION PUMP

    MDR report key: 12231290 · Received July 27, 2021

    Report

    Report Number
    2016493-2021-509928
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Report Date
    January 30, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT AND ANY SUBSEQUENT REPAIRS HAVE BEEN INVESTIGATED THROUGH THE NORMAL TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED FOR SERVICE. SERVICE RETURNS WERE FOR ISSUES NOT SIMILAR TO THE REPORTED COMPLAINT. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    CASE ID: (B)(4). CASE STATUS: OPEN. SUMMARY: ERROR CODE 305. CASE NOTES: PROBLEM DESCRIPTION 01/30/2018 09:19:15 RWHITE THERE WAS NO PATIENT INVOLVEMENT. MED SYSTEM LLL CUSTOMER BRANDON CALLED IN FOR HELP ON MED SYSTEM LLL HAS ERROR CODE 305 WHEN POWER UP UNIT. THE PROBLEM IS WITH POWER SUPPLY THAT COULD LEAD TO MEA BOARD HAD CUSTOMER TO CHARGE THE BATTERY FOR A WHILE ON UNIT THEN POWER ON FIRST SEE IF THAT CLEAR THE ERROR IF NOT. THEN FIRST TO REPLACE IS THE POWER SUPPLY BOARD AND IF THAT DOES NOT RESOLVE THE ISSUE THEN YOU HAVE THE MAIN BOARD TO REPLACE NEXT THE MEA BOARD. CONFIRM PART # 143013 FOR POWER SUPPLY BOARD AND PART # 136615 FOR MEA BOARD IR CASE # (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND ANY SUBSEQUENT REPAIRS HAVE BEEN INVESTIGATED THROUGH THE NORMAL TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE AND INDICATED THAT THIS DEVICE HAS BEEN PREVIOUSLY RETURNED FOR SERVICE. SERVICE RETURNS WERE FOR ISSUES NOT SIMILAR TO THE REPORTED COMPLAINT. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE SOURCE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128079 MEDSYTEM III INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SD 2865

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown