BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 8588960 · Received May 7, 2019

    Report

    Report Number
    9616066-2019-01287
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Report Date
    April 12, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONT'D FROM D.11: BD 10 ML SYRINGE REF 302995 LOT 9031560; BD 10 ML SYRINGE LOT 8353736 EXP 2021-12-31 0.9% NACL INJECTION; BD 3 ML SYRINGE REF 309657 LOT 8290713; BD VACUTAINER REF 364902 LOT 8304769; RADIOMETER MEDICAL APS PICO50 RADIOMETER LOTBS08 EXP 2020-08-13; SMITHS MEDICAL 3-WAY STOPCOCK REF MX5311L LOT3700212 EXP 2021-10-02; BAXTER Y-TYPE CATHETER EXTENSION SET LOT R18E02039; ICU MEDICAL SPINNING SPIROS ADAPTER LOT 3963908 EXP 2024-01-01; SMITHS MEDICAL CADD ADMINISTRATION SET LOT 3773241 EXP 2024-02-25; SMITHS MEDICAL CADD ADMINISTRATION SET LOT 3743632 EXP 2024-01-07; BARD POWER LOC (SAFETY INFUSION SET) LOTASCZS0014 EXP 2022-05-28. THE CUSTOMER¿S REPORT OF UNABLE TO INFUSE NOT CONFIRMED. VISUAL INSPECTION OF THE ASSOCIATE SET NOTED NO DAMAGE OR ANY ANOMALIES. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKING OR OCCLUSIONS. RATE ACCURACY TESTING WAS PERFORMED AND DEVICE WAS WITHIN SPECIFICATION AND THE PRIMARY SET INFUSED AT THE CORRECT RATE. DIMENSIONAL ANALYSIS FOUND THE TUBING TO BE MEASURED WITHIN SPECIFICATION. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS NOT IDENTIFIED. ANALYSIS WAS UNABLE TO REPLICATE THE EVENT DURING FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VINCRISTINE FLOWED FREELY, BUT SO SLOWLY THAT IT WAS NOT ABLE TO BE INFUSED IN 10 MINUTES EVEN WITH THE CLAMP FULLY OPEN. THERE SEEMED TO BE RESISTANCE AT THE Y-SITE. THE PATIENT HAD A PERIPHERAL IV AND WAS TO UNDERGO A "R-CHOP". NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT 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

    IT WAS REPORTED THAT VINCRISTINE FLOWED FREELY, BUT SO SLOWLY THAT IT WAS NOT ABLE TO BE INFUSED IN 10 MINUTES EVEN WITH THE CLAMP FULLY OPEN. THERE SEEMED TO BE RESISTANCE AT THE Y-SITE. THE PATIENT HAD A PERIPHERAL IV AND WAS TO UNDERGO A "R-CHOP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381324 ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION EXT TUBING

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)PRI TUBING, THERAPY DATE UNK| BD 20ML SYRINGE,BD 5ML SYRINGE, TD UNK