BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP

    MDR report key: 11317717 · Received February 11, 2021

    Report

    Report Number
    2016493-2021-25672
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    February 1, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2719-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. H3 OTHER TEXT : THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO: E2, G2 FOR BIOMED AS A HEALTH PROFESSIONAL.

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN NOTED THAT THEY FLASHED SOFTWARE FOR ERROR 13-1033-149. REPLACED FRONT COVER (BOTTOM FRONT CORNERS CRACKED), REAR CASE (BOTTOM FRONT CORNERS CRACKED), BARREL CLAMP (CRACKED HANDLE), HANDLES (CRACKED) AND LEFT/ RIGHT IUI'S (CONTAMINATED). CALIBRATED. THE FAILURE CODE OTHE WAS USED TO TRACK THE ALARIS PUMP SOFTWARE VERSION AS RECEIVED FROM THE CUSTOMER AND THE SOFTWARE VERSION WHEN DEVICE WAS SENT BACK TO THE CUSTOMER. IT DOES NOT REFLECT A DEVICE FAILURE OR REPRESENT ANY RISK TO THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 19FEB2016. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE FINDINGS, SERVICE DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO SOFTWARE ISSUE FOR ERROR 13-1033-149. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE (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 HAD CHANNEL ERROR, 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR, 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR, 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD CHANNEL ERROR, 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209453 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1