BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASADENA BAYSHORE HSP TX 1

    MDR report key: 1171925 · Received September 19, 2008

    Report

    Report Number
    1718850-2008-00028
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 26, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRIMO2X OXYGENATOR, MANUFACTURED BY INTERNATIONAL AFFILIATE IS A COMPONENT IN THE PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE PERFUSION PACK IS A PREAMENDMENT DEVICE. THIS MEDWATCH REPORT IS BEING FILED BECAUSE, THE PERFUSIONIST REPORTED THAT AIR WAS SEEN COMING FROM THE OXYGENATOR MEMBRANE TO THE ARTERIAL FILTER, AND THAT THE BUBBLE SENSOR BETWEEN THE ARTERIAL FILTER AND THE PATIENT HAD ALARMED. THE PERFUSIONIST REPORTED THAT THERE WAS NO PATIENT INJURY AND THAT THE DEVICE WAS NOT IMPLICATED IN THE INCIDENT. THEREFORE, HE DISCARDED THE DEVICE. SINCE THE DEVICE WAS NOT RETURNED, NO EVALUATION COULD BE CONDUCTED. THE SOURCE AND CAUSE OF THE REPORTED AIR COULD NOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING PATIENT REWARM, AIR WAS SEEN COMING FROM THE OXYGENATOR MEMBRANE TO THE ARTERIAL FILTER. THE PERFUSIONIST STATED THAT THE BUBBLE SENSOR, DISTAL TO THE ARTERIAL FILTER ALARMED. THE PERFUSIONIST NOTICED A SMALL AMOUNT OF AIR AT THE TOP OF THE ARTERIAL FILTER, WHICH QUICKLY CLEARED THROUGH THE PURGE LINE. THERE WERE NO OTHER ISSUES, AND THE CASE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASADENA BAYSHORE HSP TX 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0817000019

    Patients

    Seq Age Sex Outcome Treatment
    1