BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAGS 50

    MDR report key: 8518652 · Received April 16, 2019

    Report

    Report Number
    3005290010-2019-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 16, 2019
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    KSR
    PMA / PMN Number
    BK090020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE BREAKAGE WAS A CLEAR APPLICATION FAILURE BY THE CUSTOMER. THE BAGS WERE FILLED WITH A HIGHER VOLUME THAN CLEARLY INDICATED IN THE PRODUCT INFORMATION SHEET. AN OVERFILLING RESULTS IN MECHANICAL STRESS TO THE BAG THAT CAN EASILY LEAD TO A BREAKAGE. THIS WAS THE FIRST COMPLAINT WITH THIS FAILURE DESCRIPTION FOR THIS LOT. THIS ONE COMPLAINT REFERS TO 4 BAGS. COMPLAINT RATE (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS FOUR CRACKED FREEZING BAGS 50 OF LOT 6170829012. THE FREEZING BAGS WERE CRACKED AT THE FOLD LINE FROM BAG AND LABEL AREA. THE LOADED VOLUME WAS OVER 30 ML WHILE THE PRODUCT INFORMATION SHEET STATES A RECOMMENDED FILLING VOLUME OF 10-20 ML. NO OVERWRAP BAG WAS USED. DUE TO THE LOSS OF MATERIAL A SECOND TREATMENT, THAT MIGHT BE NECESSARY UNDER CERTAIN CIRCUMSTANCES, WOULD NOT BE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312304 CRYOMACS FREEZING BAGS 50 CRYOMACS FREEZING BAGS 50 KSR MILTENYI BIOTEC GMBH N/A 6170829012

    Patients

    Seq Age Sex Outcome Treatment
    1