BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL90 FLEX SOLUTION PACK

    MDR report key: 3802020 · Received February 12, 2014

    Report

    Report Number
    3002807968-2014-00005
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 10, 2014
    Report Date
    May 2, 2017
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    CEM
    PMA / PMN Number
    K092686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS FOUND DURING AN INTERNAL REVIEW AT RADIOMETER MEDICAL ON 05/01/2017: PRODUCTION HAVE ANALYZED THE SP AND FOUND THAT PIN9 DID NOT PENETRATE THE WASTE POUCH, BUT WAS BENT AND CAUSED THE WASTE TO BE IN THE BOTTOM PART OF THE SP. THE MAIN REASON WAS THAT THE WASTE POUCH WERE NOT 100% ALIGNED BY THE USER ACCORDING TO THE OPERATORS MANUAL. THIS IS TODAY A KNOWN PROBLEM AND DOCUMENTED IN NCR (B)(4).

    Description of Event or Problem · 1

    WHEN THE ICU TECHNICIAN TRIED TO REPLACE THE SOLUTION PACK FOR THE ABL90 HE SPILLED APPROXIMATELY 100 ML OF WASTE, INCLUDING PATIENT BLOOD. HE GOT MUCH OF THE WASTE ON HIS SHOES AND SOCKS, BUT NONE OF IT CAME IN CONTACT WITH HIS SKIN. NO PATIENT WAS INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92928 ABL90 FLEX SOLUTION PACK ABL90 SOLUTION PACK CEM RADIOMETER MEDICAL APS ABL90 SOLUTION PACK LI26

    Patients

    Seq Age Sex Outcome Treatment
    1