BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5FX24CM HEMO-CATH

    MDR report key: 11674733 · Received April 15, 2021

    Report

    Report Number
    2518902-2021-00021
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 21, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MSD
    UDI-DI
    00884908140835
    PMA / PMN Number
    K113487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS RECEIVED IN THE MAIL IN THE FORM OF A MEDWATCH FROM THE FACILITY. THE REPORT INDICATED THE DEVICE WAS NOT SAVED THEREFORE CANNOT BE RETURNED FOR AN EVALUATION. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION WITH NO NONCONFORMANCES OR OTHER ABNORMALITIES ASSOCIATED WITH THE DEVICE. THERE WERE NO DEVIATIONS OR PROCESS CHANGES IN THE MANUFACTURING OF THIS DEVICE. ALL INSPECTIONS AND SEQUENCE OF OPERATIONS WERE PROPERLY FOLLOWED AND DOCUMENTED. WITHOUT AN EVALUATION OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE BLUE LUMEN OF THE APHERESIS LINE WAS ACCESSED PER POLICY. THE RED LUMEN OF THE CATHETER WAS NOTED TO HAVE AIR IN IT. PATIENT STATED THAT THERE WAS AIR OBSERVED IN THE LINE THE WEEK BEFORE ALSO. SHE DENIES THE CAP COMING OFF OR ANY NOTABLE LEAKAGE. NO CRACKS WERE VISIBLE IN THE LINE BY THE APHERESIS UNIT NURSES OR SURGERY TEAM WHO CAME TO CONSULT WHEN THE AIR WAS DISCOVERED. DRESSING REMOVED BY SURGERY TEAM, HEPARIN DWELL REMOVED, AND LINE FLUSHED WITH NS WHILE THE GENERAL SURGERY RESIDENT, PA AND RN WATCHED FOR LEAKING. NO LEAKS NOTED. DUE TO UNEXPLAINED RECURRENCE OF AIR IN THE LINE AND RISK FOR HARM, A PLAN WAS MADE FOR THE CENTRAL LINE TO BE REMOVED IN THE OR. THE LINE WAS REMOVED WITHOUT COMPLICATIONS BUT THE LINE WAS NOT SAVED BY THE SURGERY TEAM IN THE OR SO WE ARE UNABLE TO SEQUESTER THE LINE FOR EXAMINATION BY THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573085 12.5FX24CM HEMO-CATH LT HEMO-CATH MSD MEDICAL COMPONENTS, INC. DMC101243 MPAM760 00884908140835

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention