BEUDAMED
    FDA Adverse Event Summary report: N

    Q CORE INFUSION ADMINISTRATOR SET AP409-01

    MDR report key: 4544473 · Received February 18, 2015

    Report

    Report Number
    3010293992-2015-00013
    Date Received
    February 18, 2015
    Date of Event
    January 24, 2015
    Report Date
    January 27, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FPA
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    EVENT REPORTED BY THE CONSUMER AT USA: "IV SET SPLIT OPEN IN AREA BETWEEN CASSETTE AND DISTAL Y-SITE. NO DETAILS CURRENTLY AVAILABLE FROM HOW THIS OCCURRED. WE ARE WORKING TO GET ADD'L INFO FROM THE PHYSICIAN REPORTING THIS ISSUE, INCLUDING LOT NUMBER AND DETAILS REGARDING HOW THE TUBING SPLIT. THE INFUSION WAS ON A PT WHEN IT SPLIT. THEY BELIEVE THIS WAS CAUGHT BEFORE ANY PT IMPACT OCCURRED." ADD'L INFO RECEIVED ON JANUARY 28, 2015: IT WAS NOTIFIED AFTER THE COMPLAINT WAS FILED THAT THE "NURSE BELIEVES THEY CAUGHT THIS BEFORE THERE WAS PT IMPACT". HOWEVER, THE PT WAS DIAGNOSED WITH A TIA (TIA - TRANSIENT ISCHEMIC ATTACK, MINI STROKE) LATER THAT DAY. WE HAVE STILL YET TO HEAR FROM THE ANESTHESIOLOGIST THAT REPORTED THIS EVENT. AS SOON AS WE HEAR MORE, WE WILL PASS IT ALONG. ADD'L INFO RECEIVED ON JANUARY 30, 2015: CANNOT VISIBLY SEE BREAK OR TEAR IN LINE THAT CONTRIBUTED TO AIR ENTERING BELOW CASSETTE. DRUG BEING INFUSED WAS NEOSYNEPHRINE. NURSE BELIEVES THEY CAUGHT THIS ISSUE BEFORE AIR COULD ENTER THE PT'S CENTRAL LINE. PT LATER IN THE DAY DID SUFFER A TIA, IT IS NOT KNOWN IF IT'S RELATED TO THE LINE BREAKING. DO NOT KNOW HOW LONG THE SET WAS ON THE PT, BUT IT WASN'T MORE THAN 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118143 Q CORE INFUSION ADMINISTRATOR SET AP409-01 INFUSION ADMINISTRATOR SET FPA Q CORE MEDICAL LTD INFUSION SET 0108.0012.14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK