BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10840253 · Received November 13, 2020

    Report

    Report Number
    2016493-2020-40229
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Report Date
    October 21, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF 8100 ERROR CODE 13-1033-149.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF 8100 ERROR CODE 13-1033-149. TECHNICAL SUPPORT- REFLASH SOFTWARE. REPLACE LOGIC BOARD. RETURN THE MODULE TO THE FACTORY. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM 08/01/2012 TO 11/10/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW HOW TO CORRECT ERROR CODE 13-1033-149.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW HOW TO CORRECT ERROR CODE 13-1033-149.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW HOW TO CORRECT ERROR CODE 13-1033-149.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO KNOW HOW TO CORRECT ERROR CODE 13-1033-149.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304267 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown