BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-C RAPID-D

    MDR report key: 3121611 · Received May 21, 2013

    Report

    Report Number
    2183996-2013-00890
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED RETURN SAMPLE WAS VISUALLY INSPECTED. UNDER THE MICROSCOPE IT IS CLEAR TO SEE THAT A LARGE FORCE HAS AFFECTED ON THE TRANSFER SET WHICH HAS LED TO A DEMOLITION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, IT WAS REPORTED THAT THE PATIENT'S MOTHER NOTICED HIS INFUSION SET TUBING WAS CRACKED AND LEAKING. SHE CHANGED THE INFUSION SET AND MADE A CORRECTION TO HIS BLOOD GLUCOSE LEVEL AND NO FURTHER PROBLEMS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224826 A-C RAPID-D INSULIN INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH 00700006932 32395282

    Patients

    Seq Age Sex Outcome Treatment
    1 002 YR