BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB

    MDR report key: 9701928 · Received February 12, 2020

    Report

    Report Number
    3004365956-2020-00045
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 27, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MEB
    PMA / PMN Number
    K090300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE AUTOFUSER OF CATALOG NUMBER MVBXL-CPNB AF W/AS 550 X 1-14ML/HR CPNB FOR ANALYSIS, LOT A181127-PSCFB000US-1. THE AUTOFUSER WAS RECEIVED IN AN LMA PAIN PUMP AND PLACED IN A PLASTIC BAG. THE BALLOON WAS EMPTY AND THE INSIDE OF THE PUMP WAS DRY; THE AUTOSELECTOR WAS SET AT 8ML/HR; THE BLUE PLUG WAS MISSING ON THE MALE LUER; THE BLUE COVER TO THE FILL PORT WAS MISSING; THE BLUE CLAMP WAS MISSING AND GLUE WAS ON THE BODY OF THE TUBE NEAR THE MALE LUER. THE PUMP WILL BE RETURNED TO THE SUPPLIER'S MANUFACTURING SITE TO PERFORM FURTHER INVESTIGATION. THE REPORTED COMPLAINT THAT THE PAIN PUMP DID NOT RELEASE MEDICATION COULD NOT BE CONFIRMED. THE ROOT CAUSE IS UNDETERMINED AND THE SAMPLE WILL BE FORWARDED TO THE SUPPLIER TO FURTHER INVESTIGATE.

    Description of Event or Problem · 0

    A PATIENT REPORTED THE PUMP INFUSED 550ML OF MEDICATION IN LESS THAN 24 HOURS. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL FOR EVALUATION, AND THERE WERE NO ADVERSE INCIDENTS OR HARM TO THE PATIENT. PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT REPORTED THE PUMP INFUSED 550ML OF MEDICATION IN LESS THAN 24 HOURS. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL FOR EVALUATION, AND THERE WERE NO ADVERSE INCIDENTS OR HARM TO THE PATIENT. PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163171 ACE MEDICAL AF W/AS 550 X 1-14ML/HR CPNB PUMP, INFUSION, ELASTOMERIC MEB TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.