BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 20370217 · Received October 4, 2024

    Report

    Report Number
    3017540705-2024-00001
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278011092
    PMA / PMN Number
    K964200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PICTURES OR AFFECTED PRODUCT SAMPLE WERE RETURNED. NO HARM OR PATIENT DEATH WAS REPORTED. NO RESPONSE PROVIDED BY THE CUSTOMER ON LOCATION OF LEAK, FLOW RATES/PRESSURE, OR WHEREABOUTS OF THE AFFECTED SAMPLE. REVIEW OF MANUFACTURING RECORDS FOR THE PER-1400, MULTIPLE PERFUSION SET (NON-STERILE) LOT 03872-062320 COMPONENTS AND FINISHED PRODUCT ALL MET ACCEPTANCE WITH NO ASSOCIATED NONCONFORMANCE'S, DEVIATIONS, OR REWORK / SORTS. MANUFACTURER MEDLINE (KIT PACKER) COMMUNICATED NO INCIDENTS OR ISSUES WITH THIS LOT OF PRODUCT. THERE HAVE BEEN NO DESIGN CHANGES AND ALL APPLICABLE DESIGN TESTING REPORTS MET ACCEPTANCE FOR NO LEAKS. COMPLAINT RECORD REVIEW FROM 2020 TO 2024 RESULTED IN NO OTHER COMPLAINTS FOR LOT 03872-062320 FOR ANY FAILURE CODES. COMPLAINT RECORD REVIEW FOR ALL MULTIPLE PERFUSION SET MODELS RESULTED IN TWO (2) PREVIOUS COMPLAINTS REPORTED FOR THE FAILURE CODE LEAKING. HOWEVER, BOTH PREVIOUS COMPLAINTS COULD NOT BE CONFIRMED OR DETERMINE CAUSE DUE TO MISSING INFORMATION (E.G., UNKNOWN LOT) AND/OR NO PICTURES / SAMPLES PROVIDED. THE COMPLAINT HISTORY YIELDED NO SYSTEMIC TREND. AT THIS TIME CONFIRMATION AND CAUSE CANNOT BE DETERMINED BASED UPON THE RECORD REVIEW WITH NO AFFECTED SAMPLE RETURNED. THEREFORE, NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PERFUSION SET LEAKING. NO PATIENT INJURY/DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713356 SURGE CARDIOVASCULAR MULTIPLE PERFUSION SET (NON-STERILE) DWF MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR PER-1400 03872-062320 00817278011092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown