BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004068499-2017-00004

    MDR report key: 6324309 · Received February 10, 2017

    Report

    Report Number
    3004068499-2017-00004
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    January 8, 2017
    Report Date
    February 10, 2017
    PMA / PMN Number
    K091656
    Removal / Correction Number
    Z-1111-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS ISSUE AND THE RECALL ACTIVITIES FOR THESE LOTS ARE IN PROGRESS. FDA WILL BE NOTIFIED UPON ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    FOUR COMPLAINTS WERE RECEIVED FROM CUSTOMERS WHO OBSERVED A "STRANGE ODOR" "EMANATING FROM THE SOLUTION" FROM SPS-1 (STATIC PRESERVATION SOLUTION) SOLUTION BAGS AND THE SOLUTION ITSELF. RELATED ORS(ORGAN RECOVERY SYSTEMS, INC.) COMPLAINT NUMBERS: RMA-002039, RMA-002080, RMA-002144, RMA-002150. LOTS INVOLVED: SPS-1_1L: PBR-0060-392, SPS-1_1L: PBR-0060-386. SPS-1_2L: PBR-0074-330, SPS-1_2L: PBR-0074-337. IN CASES WHERE THE 1L AND 2L WERE INCLUDED IN THE COMPLAINT, THE CUSTOMERS WEREN'T SURE WHICH BAG THE ODOR WAS COMING FROM. AFTER INITIAL INVESTIGATION IT IS CONFIRMED THAT THE DEVICE IS MALFUNCTIONED. COMPLAINTS WERE DETERMINED TO BE POTENTIALLY REPORTABLE. ORS MANAGEMENT DECIDED TO INITIATE A VOLUNTARY PRODUCT RECALL IN PARALLEL WITH THE INVESTIGATION. THE FDA (B)(4) OFFICE AND FDA (B)(4) OFFICE WAS NOTIFIED OF THE INITIAL ACTIONS FOR LOTS PBR-0060-392 AND PBR-0074-330 ON (B)(6) 2016. COMMUNICATION WITH THE FDA CONTINUED THROUGHOUT THE INVESTIGATION AS THE ADDITIONAL COMPLAINTS WERE RECEIVED AND ADDITIONAL ACTIONS TAKEN. DATE COMPLAINT RECEIVED FOR LOT PBR-00674-337: (B)(6) 2017. FDA RECALL NUMBER: Z-1111-2017.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other