BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8060893 · Received November 12, 2018

    Report

    Report Number
    9616066-2018-02195
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 11, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403232275
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A BALLOON IN THE PUMPING SEGMENT WAS NOT CONFIRMED. VISUAL INSPECTION FOUND NO INSTANCES OF BALLOONING AND FUNCTIONAL TESTING DID NOT REPLICATE ANY PUMP ALARMS OR BALLOON SEGMENTS. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE IV TUBING SET DEVELOPED A BALLOON IN THE PUMPING SEGMENT WHILE INSERTED IN THE PUMP MODULE AND INFUSING IV FLUIDS WHICH CAUSED THE PUMP TO ALARM THAT THERE WAS AN ERROR. THERE WAS NO IV PUSH PERFORMED PRIOR TO THE EVENT OF THE BALLOON OCCURRING IN THE SILICONE PUMPING SEGMENT. THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG, NDC (B)(4), LOT NUMBER Y274399, EXP (B)(6), POTASSIUM CHLORIDE AND 10ML BD SYRINGE, REF (B)(4), LOT NUMBER 8141801, EXP (B)(6) 2021, 0.9% SODIUM CHLORIDE. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IV TUBING SET DEVELOPED A BALLOON IN THE PUMPING SEGMENT WHILE INSERTED IN THE PUMP MODULE AND INFUSING IV FLUIDS WHICH CAUSED THE PUMP TO ALARM THAT THERE WAS AN ERROR. THERE WAS NO IV PUSH PERFORMED PRIOR TO THE EVENT OF THE BALLOON OCCURRING IN THE SILICONE PUMPING SEGMENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901240 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10879047 17107953 10885403232275

    Patients

    Seq Age Sex Outcome Treatment
    1 8100,8015, THERAPY DATE (B)(6) 2018