BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CARDIAC SURGERY PACK BO-T 46201

    MDR report key: 6388206 · Received March 8, 2017

    Report

    Report Number
    2248146-2017-00017
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 15, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 ITS RETURN. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION NOTED THAT A 3/16" Y CONNECTOR WAS USED INSTEAD OF A 1/4"Y CONNECTOR. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT AND NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. AFTER PRODUCT INVESTIGATION IT WAS DETERMINED THAT THERE WAS A 3/16"Y CONNECTOR INSTEAD OF A 1/4"Y CONNECTOR HOWEVER THE NEW DESIGN INCLUDING THE 1/4"Y CONNECTOR WAS NOT APPROVED BY THE CUSTOMER SO THE REPORTED EVENT, ALTHOUGH CONFIRMED, IS NOT CONSIDERED A NON-CONFORMITY. (B)(4).

    Description of Event or Problem · 1

    USER INDICATED THAT A 3/16 Y CONNECTOR WAS USED INSTEAD OF A 1/4" CONNECTOR PER THE DESIGN OF THE CUSTOM PACK. THIS OCCURRED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    USER INDICATED THAT A 3/16 Y CONNECTOR WAS USED INSTEAD OF A 1/4" CONNECTOR PER THE DESIGN OF THE CUSTOM PACK. THIS OCCURRED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    USER INDICATED THAT A 3/16 Y CONNECTOR WAS USED INSTEAD OF A 1/4" CONNECTOR PER THE DESIGN OF THE CUSTOM PACK. THIS OCCURRED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    USER INDICATED THAT A 3/16 Y CONNECTOR WAS USED INSTEAD OF A 1/4" CONNECTOR PER THE DESIGN OF THE CUSTOM PACK. THIS OCCURRED PRIOR TO USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172494 SMALL CARDIAC SURGERY PACK BO-T 46201 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000027824

    Patients

    Seq Age Sex Outcome Treatment
    1