BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 7.5 FR. 34CC IAB

    MDR report key: 6838473 · Received September 1, 2017

    Report

    Report Number
    2248146-2017-00337
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 8, 2017
    Report Date
    December 4, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION CONFIRMED THE PRESENCE OF FLUID INSIDE THE PACKAGING OF THE RETURNED DEVICE. IT WAS SUSPECTED THAT THE FLUID WAS SILICONE. DEVICES WERE SAMPLED AND SENT FOR INFRA-RED SPECTROPHOTOMETER (IR) TESTING. THE RESULTS CONFIRMED THAT THE SUBSTANCE WAS SILICONE WHICH HAD MIGRATED INSIDE THE PACKAGING OF THE DEVICE DURING STORAGE. SILICONE IS USED AS A LUBRICANT DURING THE MANUFACTURING PROCESS AND HAS BEEN DETERMINED TO BE BIOCOMPATIBLE. DEVICES WITH SILICONE FOUND IN THE PACKAGING CAN CONTINUE TO BE USED AND POSE NO RISK TO THE PATIENT. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE EVENT HAS BEEN CONFIRMED, THERE WAS NO MALFUNCTION OF THE REPORTED DEVICES. LOT AND SERIAL # PROVIDED IN SECTIONS ARE INDICATIVE OF THE IAB. CHANGED FROM 32 TO 33 TO REFLECT TOTAL NUMBER OF AFFECTED DEVICES. (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).

    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. WE CONTINUE OUR EFFORTS TO FOLLOW UP WITH THE CUSTOMER FOR ITS RETURN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 33 DEVICES COMPOSED OF LINEAR 7.5 FR. 34CC AND 40 CC INTRA AORTIC BALLOON CATHETER SETS WHERE PREPARATION WAS DONE BY CARDIAC SURGEON AND CATH TEAM, AND THE SETS WERE REPORTED TO HAVE LIQUID IN THEM PRIOR TO USE. IT WAS BELIEVED TO BE UNSAFE FOR PATIENT USE. THE IABS WERE REPLACED. THIS REPORT IS FOR 1 OF 33 DEVICES REPORTED 40CC IAB SET, BATCH # 3000022513. (IAB BATCH 3000019790, IAB SERIAL # (B)(4) & INSERTION KIT BATCH 3000020948.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 32 DEVICES COMPOSED OF LINEAR 7.5 FR. 34CC AND 40 CC INTRA AORTIC BALLOON CATHETER SETS WHERE PREPARATION WAS DONE BY CARDIAC SURGEON AND CATH TEAM, AND THE SETS WERE REPORTED TO HAVE LIQUID IN THEM PRIOR TO USE. IT WAS BELIEVED TO BE UNSAFE FOR PATIENT USE. THE IABS WERE REPLACED AND NOT USED ON PATIENTS. THIS MDR IS FOR 1 OF 2 OF THE REPORTED 34CC IAB SETS FROM BATCH 3000022513 (OF THE TOTAL 32 REPORTED DEVICES).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 32 DEVICES COMPOSED OF LINEAR 7.5 FR. 34CC AND 40 CC INTRA AORTIC BALLOON CATHETER SETS WHERE PREPARATION WAS DONE BY CARDIAC SURGEON AND CATH TEAM, AND THE SETS WERE REPORTED TO HAVE LIQUID IN THEM PRIOR TO USE. IT WAS BELIEVED TO BE UNSAFE FOR PATIENT USE. THE IABS WERE REPLACED AND NOT USED ON PATIENTS. THIS MDR IS FOR 1 OF 2 OF THE REPORTED 34CC IAB SETS FROM BATCH 3000022513 (OF THE TOTAL 32 REPORTED DEVICES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619056 LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000019790

    Patients

    Seq Age Sex Outcome Treatment
    1