BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11138934 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-03698
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    February 4, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, RETESTED, AND RELEASED BACK TO THE CUSTOMER. 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 REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE REAR- DAMAGED/CRACKED AIL SENSOR ASSEMBLY- CRACKED HOUSING CASE FRONT- DAMAGED/CRACKED NON SUPPORTED PART INSTALLED RECALL AFFECTED THERE WAS NO PATIENT INVOLVEMENT RESERIALIZATION AND ANY NECESSARY REPAIR- 02/04/2020 09:19:16 LAURYNE WASAN (LWASAN) NPI CONFIRMED. NEW SERIAL NUMBER ASSIGNED TO SERIAL NUMBER DUE TO DUPLICATE SERIAL NUMBER, (B)(4). CUSTOMER, MICHELE GMEREK, AT 864.455.3261 CONFIRMED DUPLICATE AND IS AWARE OF THE RESERIALIZATION PROCESS. NEW SN 2001353 / HOSPITAL ASSET TAG # 116680 IS BEING ASSIGNED TO RMA 301553781. 4FEB2020LW

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38893 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1