BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 8685104 · Received June 10, 2019

    Report

    Report Number
    9616066-2019-01605
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 11, 2019
    Report Date
    May 22, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED FROM D11; 1000 ML B BRAUN BAG LOT J8L807 REF E800 EXP 03/21 0.9% SODIUM CHLORIDE INJECTION. THE CUSTOMER¿S REPORT THAT THE TUBING SPIKE BROKE WAS CONFIRMED. IT WAS OBSERVED THAT THE SPIKE TIP OF THE DRIP CHAMBER WAS BROKEN OFF. THE BROKEN OFF SPIKE TIP WAS NOT RECEIVED FOR INSPECTION. FURTHER INSPECTION OF THE DAMAGED SPIKE SURFACE OBSERVED THE BREAKAGE TO BE ROUGH AND UNEVEN. A WHITISH COLORED STRESS MARKING WAS ALSO NOTED WITHIN THE INFUSION BAG'S PORT OPENING. IT WAS FURTHER NOTED THAT THE INFUSION BAG'S PORT OPENING TO BE VERY FIRM AND RIGID WITH MINIMAL FLEXIBILITY. THE BREAKAGE WAS CAUSED BY AN EXTERNAL LATERAL FORCE. THE ROOT CAUSE OF THE EXTERNAL LATERAL FORCE WAS NOT IDENTIFIED. THE REPORTED SECONDARY SET, (MODEL/LOT UNKNOWN) USED DURING THE REPORTED EVENT WAS NOT RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE NURSE WAS REMOVING THE SECONDARY IV BAG OF ANTIBIOTICS TO SPIKE A NEW ONE, SHE NOTICED THAT THE SPIKE WAS FLAT AND BROKEN. THE NURSE REMOVED THE TUBING AND REPLACED IT WITH A NEW SET THAT WAS CONNECTED TO AN ADULT PATIENT. THERE WAS NO HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: 1000 ML B BRAUN BAG, LOT J8L807, REF E800, EXP 03/2021, 0.9% SODIUM CHLORIDE INJECTION. NO PRODUCT RETURNED. BECAUSE NO PRODUCT WAS RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE NURSE WAS REMOVING THE SECONDARY IV BAG OF ANTIBIOTICS TO SPIKE A NEW ONE, SHE NOTICED THAT THE SPIKE WAS FLAT AND BROKEN. THE NURSE REMOVED THE TUBING AND REPLACED IT WITH A NEW SET THAT WAS CONNECTED TO AN ADULT PATIENT. THERE WAS NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475408 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 2426-0007, THERAPY DATE (B)(6) 2019| SEC TUBING