BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11035552 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-73341
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    July 30, 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 CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, RETESTED, AND RETURNED 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 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    SERVICE: ALARM - ERROR CODES / MESSAGES DISPLAY BOARD- SEGMENT DIM ALARM - ERROR CODES / MESSAGES- 07/30/2019 11:48:02 RFC_REPAIRS (RFC_REPAIRS) PO FOR $365. 08/07/2019 14:42:28 ARJEL ANCHETA (ARJEANCH) INBOUND ERROR 08/12/2019 06:37:04 QUIRINO C GUARIN (QGUARIN) NO FAULT FOUND BUT ERROR LOG CONTAIN NUMEROUS ENTRIES OF ERROR 200.5040, THIS ERROR IS SOFTWARE INCOMPATABILITY, CUSTOMER ATTACHED THIS UNIT TO A PCU WITH INCOMPATIBLE SOFTWARE. VERIFIED CUSTOMER SOFTWARE IN XDO3 AND ZSM0054 AND DEVICE HAS THE CORRECT SOFTWARE. 08/12/2019 12:03:02 QUIRINO C GUARIN (QGUARIN) REPLACED U4 ON DISPLAY PCB FOR DIM SEGMENT. 08/12/2019 12:05:00 MARITES MALIG (MMALIG) PHONE 858-458-7000 7000 INSPECTED SOLDER U4 ON DISPLAY BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504170 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1