BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXGUARD SECONDARY SET

    MDR report key: 2940508 · Received December 19, 2012

    Report

    Report Number
    9616066-2012-00904
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K051499
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE SET BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A CUSTOMER IS HAVING A PROBLEM WITH IV SETS BREAKING AT THE LUER. THE CURSE REPORTED TO HIM THAT HE MALE TIPS ARE BREAKING OFF AT THE LUER END OF THE SECONDARY TUBING WHEN THEY REMOVE THE TUBING. THE CUSTOMER REPORTED THEY ARE SWABBING THE SMARTSITES ON THE PRIMARY TUBING WITH CHLORHEXIDINE AND LETTING IT DRY FOR 15 SECONDS BEFORE THEY ATTACH THE SECONDARY TUBING. NO PT HARM OR MEDICAL INTERVENTION REPORTED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXGUARD SECONDARY SET FPA CAREFUSION CORP MS3500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| THERAPY DATE UNK| ALARIS PUMP MODULE, SN UNK