BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6637185 · Received June 13, 2017

    Report

    Report Number
    9616066-2017-00834
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    December 21, 2016
    Report Date
    May 9, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100 ML BAXTER BAG NDC 0338-0709-48, LOT NUMBER: 354456, EXP: SEP 2017, POTASSIUM CHLORIDE. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    OMIT 2420-0007 FROM CONCOMITANT PRODUCTS. THE CUSTOMER¿S REPORT OF A FLUID LEAK FROM AN IV SET WAS CONFIRMED AND REPLICATED. NO ANOMALIES WERE OBSERVED DURING INITIAL VISUAL INSPECTION. FUNCTIONAL TESTING WAS PERFORMED; A LEAK WAS OBSERVED NEAR THE UPPER END OF THE PUMP SEGMENT. MICROSCOPIC INSPECTION REVEALED A SMALL, JAGGED TEAR IN THE SILICONE TUBING, JUST BELOW THE UPPER RETAINER RING. BOTH UPPER AND LOWER RETAINER RINGS WERE NOTED TO BE PRESENT ON EITHER END OF THE TUBING. THE ROOT CAUSE OF THE TEAR COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED FROM THE IV SET DURING A SECONDARY INFUSION OF POTASSIUM. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAKED FROM THE PRIMARY IV SET DURING A SECONDARY INFUSION OF POTASSIUM. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417032 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 2420-0007, THERAPY DATE (B)(6) 2016