BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® EXTENSION SET

    MDR report key: 7857360 · Received September 7, 2018

    Report

    Report Number
    9616066-2018-01581
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    August 14, 2018
    Report Date
    August 15, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233647
    PMA / PMN Number
    K790108
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONT'D MEDICAL DEVICES: (2)8100;8015;(2)PRI TUBING;20129E;CENTRAL LINE; THERAPY DATE (B)(6) 2018. THE CUSTOMER'S COMPLAINT OF A CRACKED AND LEAKING FILTER COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NVN (TPN ) WAS INFUSING ON A NICU PATIENT AT A RATE OF 4ML/HR (VTBI 98ML) AND LIPIDS 20% WAS INFUSING AT 1.1 ML/HR (VTBI 22ML). THE NURSE REPORTED THAT THE LIPID INFUSION WAS TURNED OFF FROM 1800- 2232 (LIPIDS ONLY INFUSE FOR 20 HOURS PER THEIR HOSPITAL PROTOCOL). AT 2100 THE NURSE NOTICED A STICKY FLUID LEAKING AND A CRACK AT THE NVN FILTER. NEW BAGS OF BOTH NVN AND LIPIDS WERE DUE TO BE HUNG SOON AFTER, SO THE NURSE DECIDED TO DO A COMPLETE NEW TUBING SET-UP, EVEN THOUGH THE SETS WERE IN USE FOR LESS THAN 96 HRS. AT 2232 THE ENTIRE TUBING SET UP WAS CHANGED AND NEW BAGS OF NVN(TPN) AND LIPIDS WERE HUNG. THE PUMPS WERE THEN RESTARTED HOWEVER BOTH ALARMED FOR OCCLUSION A FEW TIMES. AT THAT TIME THE NURSE ATTEMPTED TO FLUSH THE PICC LINE BUT WAS UNABLE TO FLUSH. THE NURSE PRACTITIONER DISCONTINUED THE PICC LINE AND RESTARTED A PERIPHERAL IV AND THE PATIENT WAS PLACED ON CLEAR FLUIDS FOR THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699229 ALARIS® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10011865 18055178 10885403233647

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention