BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7LPM

    MDR report key: 6615522 · Received June 6, 2017

    Report

    Report Number
    2248146-2017-00045
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    May 12, 2017
    Report Date
    February 27, 2020
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: INITIAL MDR SECTION G5 PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT RECORD # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY THAT CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7LPM HAD MULTIPLE CRACKED CONNECTIONS.

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REQUESTED BY THE EVALUATOR THAT THE DEVICE NOT GET SANITIZED PRIOR TO THE EVALUATION SINCE THE EVENT OCCURRED PRIOR TO CLINICAL USE, DURING PRIMING. THE KIT AND TRAY WERE RETURNED. THE TRAY DID NOT EXHIBIT ANY SIGNS OF DAMAGE. A VISUAL AND PHOTOGRAPHIC INSPECTION WAS PERFORMED FOR THE BROKEN PORT OF QUADROX-ID ADULT. DURING THE INVESTIGATION IT WAS NOTED THAT THE OUTER CARTON WAS NOT RETURNED AND THEREFORE DAMAGE COULD NOT BE REVIEWED. THE KIT AND TRAY WERE RETURNED. THE TRAY DID NOT EXHIBIT ANY SIGNS OF DAMAGE. THE MOST LIKELY ROOT CAUSE OF THE PORTS BEING BROKEN CAN BE ATTRIBUTED TO ROUGH HANDLING DURING SHIPPING. OTHER MEASURE SUCH AS PALLETIZING THE CARTONS, MORE STRAPS AND A LARGER TRAY WILL BE REVIEWED WITH THE CUSTOMER TO INCREASE THE SHIPPING PROTECTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7 LPM HAD MULTIPLE CRACKED CONNECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7 LPM HAD MULTIPLE CRACKED CONNECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7LPM HAD MULTIPLE CRACKED CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397432 CUSTOM TUBING PACK BEQ-TOP 25003 3/8X3/8 TO 7LPM TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000044052

    Patients

    Seq Age Sex Outcome Treatment
    1