BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-TOP 22701 CUSTOM TUBING PACK

    MDR report key: 6912545 · Received October 3, 2017

    Report

    Report Number
    2248146-2017-00435
    Event Type
    Malfunction
    Date Received
    October 3, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. (B)(4).

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PRODUCT WAS NOT RETURNED FOR EVALUATION, A VISUAL REVIEW OF THE PROVIDED PICTURES DETERMINED THE REPORTED MANIFOLD CAPS WERE NOT PRESENT AND THERE WAS A KINK IN THE TUBING. THE EVALUATION OF THE PICTURES PROVIDED CONFIRMED THE REPORTED EVENT. ADDITIONALLY, PER THE INVESTIGATION REPORT, A REVIEW OF MANUFACTURING RECORDS, MANUFACTURING PROCESS, AND A SAMPLE FROM THE SAME BATCH WAS PERFORMED. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. FISHBONE ANALYSIS OF BOTH EVENTS WAS UNABLE TO DETERMINE THE MOST LIKELY CAUSES FOR EITHER FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A KINK THAT AFFECTS IT'S PERFORMANCE. WHEN THE SHUNT WAS OPENED IT WAS MISSING CAPS ON TWO PORTS AND THE PACKAGE WAS SEALED SHUT. THERE WERE NO LOOSE CAPS IN THE PACKAGE. THE PRODUCT WAS NOT USED ON A PATIENT AND THEREFORE NO RISK FOR HARM OR INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A KINK THAT AFFECTS IT'S PERFORMANCE. WHEN THE SHUNT WAS OPENED IT WAS MISSING CAPS ON TWO PORTS AND THE PACKAGE WAS SEALED SHUT. THERE WERE NO LOOSE CAPS IN THE PACKAGE. THE PRODUCT WAS NOT USED ON A PATIENT AND THEREFORE NO RISK FOR HARM OR INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOM TUBING PACK HAD A KINK THAT AFFECTS IT'S PERFORMANCE. WHEN THE SHUNT WAS OPENED IT WAS MISSING CAPS ON TWO PORTS AND THE PACKAGE WAS SEALED SHUT. THERE WERE NO LOOSE CAPS IN THE PACKAGE. THE PRODUCT WAS NOT USED ON A PATIENT AND THEREFORE NO RISK FOR HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689014 BEQ-TOP 22701 CUSTOM TUBING PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000029421

    Patients

    Seq Age Sex Outcome Treatment
    1