BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10784632 · Received November 4, 2020

    Report

    Report Number
    2016493-2020-32529
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Report Date
    March 14, 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. (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 HAS LESS THAN ONE HOUR. THIS DEVICE MEETS THE CRITERIA PER (B)(4) OUT-OF-BOX FAILURE PROCESSING DOCUMENT # (B)(4) FOR RESTOCKING BACK TO FINISHED GOODS WAREHOUSE. (B)(4). PROBLEM DESCRIPTION: CRACK IN LIGHT HOUSE ASSEMBLY. DESCRIPTION: 8100, LVP M2 LAB OBSERVATIONS (CONDITION OF UNIT AS RECEIVED): THE LVP HAS CRACKED ON DOOR AND DOOR COVER. INVESTIGATION SUMMARY: LVP WAS HIT HARD BY EXTERNAL FORCE CAUSING THE LIGHT HOUSE TO CRACK. LIGHT HOUSE IS PART OF THE DOOR ASSEMBLY. THE DOOR COVER IS ALSO CRACK. CONCLUSION: ROOT CAUSE IS HANDLING. REWORK: REPLACE DOOR COVER TC10010832 AND DOOR TC10010213. DISPOSITION: ROUTE TO SERVICE FOR NORMAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248379 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1