BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARI PUMP MODULE ADMINISTRATION SET

    MDR report key: 9340706 · Received November 19, 2019

    Report

    Report Number
    9616066-2019-03323
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 30, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT GRID REVISED-SUSPECT CHANGED FROM PRI TUBING TO 2426-0500. THE CUSTOMER REPORT THAT THE SET'S MALE LUER BROKE (SEPARATED) WAS CONFIRMED BASED ON HANDLING AND INSPECTION. MANUAL HANDLING BY SLIGHTLY TUGGING THE SET¿S ENGAGEMENTS OBSERVED A SEPARATION AT THE ENGAGEMENT BETWEEN THE TUBING AND MALE LUER COMPONENTS. THE SET WAS VISUALLY INSPECTED FOR HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. FURTHER INSPECTION OF THE SEPARATED TUBING END OBSERVED NO SOLVENT TRACES. NO OBVIOUS DAMAGE OR ANY ISSUE WAS OBSERVED. NO TESTING WAS DEEMED NECESSARY DUE TO THE SEPARATION. INSPECTION UNDER MAGNIFICATION OBSERVED NO SOLVENT TRACES. DIMENSIONAL ANALYSIS OF THE SEPARATED TUBING NOTED IT WAS WITHIN SPECIFICATION(S). THE ROOT CAUSE IS INSUFFICIENT SOLVENT DUE TO EQUIPMENT AND/OR OPERATOR ERROR.

    Additional Manufacturer Narrative · 0

    CONTINUED FROM D11-250ML BAXTER BAG LOT: Y311035 EXP: DEC20, EPINEPHRINE (ADRENALIN) 64 MCG/ML IN 0.9% SODIUM CHLORIDE INJECTION;TWO USED 10ML BD SYRINGES LOT: 9175822 EXP: 2022-06-30, 0.9% SODIUM CHLORIDE INJECTION;TWO NON-BD SYRINGE CONNECTORS;TWO USED EXTENSION SETS IDENTIFIED TO BE 30914 MICROBORE SETS;ONE USED 10ML BD SYRINGE LOT: 9150969 EXP: 2022-04-30, 0.9% SODIUM CHLORIDE INJECTION; 60ML BD SYRINGE FAT EMULSION (INTRALIPID) 20% INFUSION;NON-BD SYRINGE CONNECTOR THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED AT 0500 A CONTINUOUS INFUSION OF EPINEPHRINE 64MCG/ML IN NACL 0.9% 250ML WAS INITIATED. AT AN UNSPECIFIED TIME, IT WAS NOTED THAT THE TUBING SET MALE LUER WAS BROKEN AT THE CONNECTION CAP. THE PATIENT REMAINED HYPOTENSIVE AND REQUIRED AN INCREASED EPINEPHRINE DOSE, AND FLUID BOLUS TO COUNTERACT THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF EPINEPHRINE 64MCG/ML IN NACL 0.9% 250ML, THE TUBING MALE LUER BROKE AT CONNECTION CAP. THE PATIENT REMAINED HYPOTENSIVE AND REQUIRED AN INCREASED EPINEPHRINE DOSE AND FLUID BOLUS TO COUNTERACT THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INFUSION OF EPINEPHRINE 64MCG/ML IN NACL 0.9% 250ML, THE TUBING MALE LUER BROKE AT CONNECTION CAP. THE PATIENT REMAINED HYPOTENSIVE AND REQUIRED AN INCREASED EPINEPHRINE DOSE AND FLUID BOLUS TO COUNTERACT THE EVENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING CRACKED/BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135983 ALARI PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention