BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K133532

    MDR report key: 11265722 · Received February 2, 2021

    Report

    Report Number
    2016493-2021-22362
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    April 30, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF A REAR CASE ISSUE ARE CRACKED IS CONFIRMED BASED ON A CLASS III FIELD CORRECTION; HOWEVER NO PRODUCT WAS RETURNED FOR THIS FILE. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE. DEVICE HISTORY RECORD (DHR) REVIEWS ARE NOT REQUIRED FOR FIELD ACTION COMPLAINTS BECAUSE THE ROOT CAUSE OF THE ISSUE IS KNOWN, THE INVESTIGATION IS DOCUMENTED WITHIN A CAPA, AND A FIELD ACTION HAS BEEN INITIATED. THE DEVICE IS USED FOR TREATMENT PURPOSES. 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 NOT RETURNED FOR SERVICING WHICH NOT 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

    IT WAS REPORTED THAT THE CUSTOMER IS REPLACING THE KIT SHIELDED REAR CASE ASSY PCU 1.5 AS THEY ARE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162686 K133532 PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1