BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 11668119 · Received April 14, 2021

    Report

    Report Number
    2016493-2021-502553
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    February 26, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    MEA
    UDI-DI
    10885403812002
    PMA / PMN Number
    K043299
    Removal / Correction Number
    Z-2720-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THE DEVICE WAS REPLACED WITH BROKEN FLANGE GRIPPER RETAINER, REAR CASE, LATCH MODULE, CRACK FRONT COVER, LEFT HANDLE, LOCK LABEL, BARREL CLAMP, FRONT DOOR AND REAR DOOR, DISCOLORED FLANGE GRIPPER, WORN WIPER SEAL AND CONTAMINATED LEFT IUI. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE CUSTOMER DAMAGE OF THE SYR/PCA PL FLG GRIPPER RTNR. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN: (B)(6) WAS PERFORMED, WHICH SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 13SEP2007 AND CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE SN: (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN OR DAMAGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561255 ALARIS PCA MODULE PUMP, FUSION MEA CAREFUSION SD 8120 10885403812002

    Patients

    Seq Age Sex Outcome Treatment
    1