BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10077736 · Received May 21, 2020

    Report

    Report Number
    2016493-2020-01066
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    August 7, 2019
    Report Date
    April 23, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: D.11

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: G.3

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6) ON AN ORTHOPEDIC UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6) ON AN ORTHOPEDIC UNIT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION. NO PATIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BOTTLE SIDE PRESSURE SENSOR ERROR CODE 240.4150. THERE WAS NO PATIENT HARM REPORTED. THE ISSUE OCCURRED AT (B)(6) HOSPITAL ON AN ORTHOPEDIC UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543074 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 8015, TD (B)(6)2019| PRI TUBING, TD (B)(6) 2019| 8015, TD: (B)(6) 2019.