BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-TOP 47600 LTX W/PEDI HSVR W/ORF32

    MDR report key: 6756691 · Received August 1, 2017

    Report

    Report Number
    2248146-2017-00192
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 10, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    09/07/2017 (B)(4): PRODUCT WAS NOT SANITIZED AS PER INVESTIGATOR REQUEST, SINCE IT WAS ONLY PRIMED AND WAS NEVER USED ON A PATIENT. AS PER THE INVESTIGATION REPORT, A VISUAL INSPECTION DETERMINED THAT ONLY PART OF THE PACK WAS RETURNED FOR ANALYSIS, HOWEVER THE BROKEN PORT ON THE PALL LG6 ARTERIAL FILTER WAS CONFIRMED. AS PER THE INVESTIGATION REPORT, THE MOST LIKELY CAUSE OF THE CONFIRMED BROKEN PORT ON THE PALL LG6 ARTERIAL FILTER WAS DETERMINED TO BE ROUGH HANDLING. WHEN THE ROUGH HANDLING OCCURRED COULD NOT BE CONCLUSIVELY DETERMINED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4); RECORD # (B)(4). 09/06/2017 (B)(4): PRODUCT WAS NOT SANITIZED AS PER INVESTIGATOR REQUEST, SINCE IT WAS ONLY PRIMED AND WAS NEVER USED ON A PATIENT. PER ATTACHED FAILURE EVALUATION, A VISUAL INSPECTION DETERMINED THAT ONLY PART OF THE PACK WAS RETURNED FOR ANALYSIS,HOWEVER THE BROKEN PORT ON THE PALL LG6 ARTERIAL FILTER WAS CONFIRMED. PER ATTACHED FAILURE EVALUATION, THE MOST LIKELY CAUSE OF THE CONFIRMED BROKEN PORT ON THE PALL LG6 ARTERIAL FILTER WAS DETERMINED TO BE ROUGH HANDLING. WHEN THE ROUGH HANDLING OCCURRED COULD NOT BE CONCLUSIVELY DETERMINED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4); RECORD # (B)(4).

    Additional Manufacturer Narrative · 1

    PMA/510(K)# CHANGED FROM : K08059223 TO: K080592. COMPLAINT # (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 THAT DURING CIRCUIT SET-UP AND REMOVAL OF CUSTOM TUBING PACK FROM STERILE TUBING PACK, CLINICIAN NOTED THAT THE SHUNT LINE FROM THE LGB FILTER HAD BROKEN OFF OF THE FILTER HOUSING AND COULD NOT BE USED. IT WAS FOUND THAT THE SHUNT LINE WAS BROKEN FROM THE HOUSING OF THE LGB FILTER WHEN REMOVED FROM THE SHIPPING PACK DURING CIRCUIT SET-UP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CIRCUIT SET-UP AND REMOVAL OF CUSTOM TUBING PACK FROM STERILE TUBING PACK, CLINICIAN NOTED THAT THE SHUNT LINE FROM THE LGB FILTER HAD BROKEN OFF OF THE FILTER HOUSING AND COULD NOT BE USED. IT WAS FOUND THAT THE SHUNT LINE WAS BROKEN FROM THE HOUSING OF THE LGB FILTER WHEN REMOVED FROM THE SHIPPING PACK DURING CIRCUIT SET-UP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CIRCUIT SET-UP AND REMOVAL OF CUSTOM TUBING PACK FROM STERILE TUBING PACK, CLINICIAN NOTED THAT THE SHUNT LINE FROM THE LGB FILTER HAD BROKEN OFF OF THE FILTER HOUSING AND COULD NOT BE USED. IT WAS FOUND THAT THE SHUNT LINE WAS BROKEN FROM THE HOUSING OF THE LGB FILTER WHEN REMOVED FROM THE SHIPPING PACK DURING CIRCUIT SET-UP. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536531 BO-TOP 47600 LTX W/PEDI HSVR W/ORF32 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE DATASCOPE FAIRFIELD 3000026971

    Patients

    Seq Age Sex Outcome Treatment
    1