BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5 FR. 40CC IAB

    MDR report key: 6719478 · Received July 17, 2017

    Report

    Report Number
    2248146-2017-00166
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 28, 2017
    Report Date
    August 18, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    08/18/2017 (B)(4): THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. THE SHEATH AND EXTENDER TUBING WERE ALSO RETURNED. AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER, Y-FITTING, EXTRACORPOREAL AND EXTENDER TUBING WAS PERFORMED AND NO LEAKS WERE DETECTED. THE IAB WAS PLACED ON THE CS300 PUMP AND PUMPED FOR TWO HOURS WHICH REPRESENTS ONE COMPLETE AUTO FILL CYCLE. THE IAB PUMPED NORMALLY AND NO ALARM SOUNDED FROM THE PUMP. AN EVALUATION OF THE PRODUCT WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE PRODUCT PERFORMED ACCORDING TO SPECIFICATION. A DEVICE AND 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 # 141777.

    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 THAN ON (B)(6) 2017 INTRA-AORTIC BALLOON (IAB) THERAPY BEGAN. ON (B)(6) 2017, ALARM ¿RAPID GAS LOSS¿ WAS GENERATED FOR THREE TIMES DURING THERAPY. THE IAB WAS REPLACED AND THERAPY CONTINUED. SEVERE TORTUOSITY WAS NOTED IN THE PATIENT VESSEL. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAN ON (B)(6) 2017 INTRA-AORTIC BALLOON (IAB) THERAPY BEGAN. ON (B)(6) 2017, ALARM ¿RAPID GAS LOSS¿ WAS GENERATED FOR THREE TIMES DURING THERAPY. THE IAB WAS REPLACED AND THERAPY CONTINUED. SEVERE TORTUOSITY WAS NOTED IN THE PATIENT VESSEL. THERE WAS NO INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499993 TRANS-RAY PLUS 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000043969

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR