BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUMA RMC HORIZON DIST YUMA AZ1

    MDR report key: 1139788 · Received August 28, 2008

    Report

    Report Number
    1718850-2008-00023
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 21, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    K021830
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VANGUARD IS MANUFACTURED BY SORIN GROUP AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 089104003, IS A PRE-AMENDMENT DEVICE. ONE VANGUARD CARDIOPLEGIA DEVICE WAS RETURNED TO SORIN GROUP USA, INC. FOR EVALUATION. A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. THE UNIT WAS RETURNED TO SORIN GROUP FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WITH SORIN GROUP FINDINGS.

    Description of Event or Problem · 1

    AFTER THE PERFUSIONIST DELIVERED THE FIRST DOSE OF CARDIOPLEGIA, HE NOTICED AIR IN THE LINE GOING TO THE PATIENT. THE AIR WAS CLEARED PRIOR TO ANY PATIENT INVOLVEMENT. THE PERFUSIONIST CHANGED OUT THE UNIT PRIOR TO THE NEXT CARDIOPLEGIA DOSE. THERE WAS NO ADVERSE PATIENT AFFECT DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUMA RMC HORIZON DIST YUMA AZ1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 0807700047

    Patients

    Seq Age Sex Outcome Treatment
    1 NP