BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11106644 · Received January 4, 2021

    Report

    Report Number
    2016493-2020-82694
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    November 8, 2019
    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 DEVICE CAME IN FOR UNKNOWN REASONS. 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

    UNEXPECTED RETURN- (B)(4). UNIT RECEIVED IN SERVICE DEPOT AS UNEXPECTED. A NEW SN HAS BEEN CREATED TO ACCOUNT FOR THE UNIT IN OUR DEPOT. INFORMATION TO UPDATE THE RMA TO BE CONFIRMED BY CUSTOMER. SERIAL NUMBER 2001325 IS THE SERIAL NUMBER ASSIGNED TO RMA 301532457. SERIAL NUMBER RE-ASSIGNMENT REQUIRED TO RECONCILE A MISMATCH BETWEEN THE INTERNALLY PROGRAMMED SERIAL NUMBER AND THE EXTERNALLY APPLIED SERIAL NUMBER LABELING. THE FOLLOWING SERIAL NUMBERS OR PARTIAL SERIAL NUMBERS WERE FOUND (B)(4)(EXTERNAL) & (B)(4) (INTERNAL). THESE SERIAL NUMBERS HAVE BEEN FLAGGED AS INACTIVE TO BE RE-SERIALIZED SHOULD THEY RETURN TO CAREFUSION FOR SERVICE. JOSEPH PRICE AT [email protected] HAS BEEN NOTIFIED THAT THE MISMATCHED SERIAL NUMBERS WILL BE DEACTIVATED AND THAT A NEW SERIAL NUMBER (2001325) HAS BEEN ASSIGNED TO THEIR HOSPITAL. 8NOV2019W

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5090 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1