BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    MDR report key: 6274549 · Received January 24, 2017

    Report

    Report Number
    2248146-2017-00005
    Event Type
    Malfunction
    Date Received
    January 24, 2017
    Date of Event
    December 30, 2016
    Report Date
    March 7, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DWE
    PMA / PMN Number
    K08059223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENT - ADDITIONAL INFORMATION. DATE RECEIVED BY MFG CORRECTED TO 12/31/2016.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WE'RE UNABLE TO COMPLETE AN EVALUATION ON THE AFFECTED PRODUCT. WHEN IT'S PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH ADDITIONAL FINDINGS. WE CONTINUE IN OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR IT'S RETURN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND SO COULD NOT BE EVALUATED. WE ARE UNABLE TO CONFIRM THIS COMPLAINT. THE COMPLAINT HISTORY REVIEW IS NOT ABLE TO BE PERFORMED SINCE THE LOT INFORMATION WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THE CIRCUIT LEAKED AT THE POST PUMP OUTLET DURING A BLOOD PRIME. THE CONNECTOR WAS OK. WE REPLACE THE TUBING BEFORE WE WENT ON. NO PATIENT WAS INVOLVED. NO DEATH OR INJURY WAS REPORTED. SEGMENT OF THE CIRCUIT WAS DISCARDED. FURTHER CLARIFICATION, IT WAS A VERY TINY LEAK AT THE CONNECTOR WHERE IT REDUCES FROM THE OUTLET OF THE ROTOFLOW 3/8 TUBING AND REDUCES TO THE 1/4 INCH TUBING. THEY REPLACED THIS SEGMENT OF THE CIRCUIT AND USED IT IN THE CASE. NO LOT NUMBER AVAILABLE.

    Description of Event or Problem · 1

    THE CIRCUIT LEAKED AT THE POST PUMP OUTLET DURING A BLOOD PRIME. THE CONNECTOR WAS OK. WE REPLACE THE TUBING BEFORE WE WENT ON. NO PATIENT WAS INVOLVED. NO DEATH OR INJURY WAS REPORTED. SEGMENT OF THE CIRCUIT WAS DISCARDED. FURTHER CLARIFICATION, IT WAS A VERY TINY LEAK AT THE CONNECTOR WHERE IT REDUCES FROM THE OUTLET OF THE ROTOFLOW 3/8 TUBING AND REDUCES TO THE 1/4 INCH TUBING. THEY REPLACED THIS SEGMENT OF THE CIRCUIT AND USED IT IN THE CASE. NO LOT NUMBER AVAILABLE.

    Description of Event or Problem · 1

    THE CIRCUIT LEAKED AT THE POST PUMP OUTLET DURING A BLOOD PRIME. THE CONNECTOR WAS OK. WE REPLACE THE TUBING BEFORE WE WENT ON. NO PATIENT WAS INVOLVED. NO DEATH OR INJURY WAS REPORTED. SEGMENT OF THE CIRCUIT WAS DISCARDED. FURTHER CLARIFICATION, IT WAS A VERY TINY LEAK AT THE CONNECTOR WHERE IT REDUCES FROM THE OUTLET OF THE ROTOFLOW 3/8 TUBING AND REDUCES TO THE 1/4 INCH TUBING. THEY REPLACED THIS SEGMENT OF THE CIRCUIT AND USED IT IN THE CASE. NO LOT NUMBER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56867 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1