BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11035308 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-73225
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    July 30, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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¿S REPORTED PROBLEM WAS CONFIRMED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00783587 CASE SUBJECT: NPI 8100 ERROR 241.4140 ACCOUNT NAME: BROOKE ARMY MEDICAL CENTER ACCOUNT #: 10060959 ASSET NAME: MEDSTATION,3500,AUX,7-DRAWER ASSET LOCATION: CONTACT: ALLEN GRAY CONTACT EMAIL: (B)(6). CONTACT PHONE: 210-539-1222 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: BIOMED HAS A 8100 UNIT GIVING HIM A 241.4140 ERROR. SN: (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: THE SERIAL NUMBER THE BIOMED GAVE SHOWS UP AS A MEDSTATION 3500 UNIT. RECOMMEND TO THE BIOMED TO REPLACE THE PATIENT SIDE PRESSURE SENSOR. GAVE PART NUMBER AND TRANSFER TO COM FOR PRICING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500306 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1