BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10807205 · Received November 9, 2020

    Report

    Report Number
    2016493-2020-33953
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Report Date
    May 23, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACKWISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). AFTER INVESTIGATION, THE DEVICE MODULE RUN TIME WAS 0 HOURS. THIS DEVICE MEETS THE CRITERIA PER (B)(4). PROBLEM DESCRIPTION: FAILED TESTING LAB OBSERVATIONS (CONDITION OF UNIT AS RECEIVED): THE MODULE WAS RECEIVED IN GOOD CONDITION. INVESTIGATION SUMMARY: CONFIRM COMPLAINT AT POWER UP ON BENCH AND BY ERROR LOG. CODE 211-2000 DISPLAYED AND DEFINED AS (B)(4) FAILURE, RUNTIME FATAL SEVERITY. OBSERVATION: SEGMENT TOO BRIGHT. ISSUE: PINCHED DISPLAY HARNESS, INSULATION ON BLUE AND RED WIRES BROKEN, WIRES THEREFORE SHORTED CAUSING CODE 211-2000. CONFIRMED BY INSPECTION AND SIMULATED BY ISOLATING WIRES AND SHORTING RELATED PINS ON CONNECTOR J2, CONFIRMED WITH ALARM CODE 211-200 BEING DISPLAYED. CONCLUSION: ASSEMBLY ISSUE. QA TO BE ALERTED. REWORK: REPLACE TC10010751 FOR M2. DISPOSITION: ROUTE TO SERVICE FOR NORMAL PROCESS. (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272962 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1