BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP82200 I MIRANDOLA

    MDR report key: 2538444 · Received April 6, 2012

    Report

    Report Number
    1718850-2012-00040
    Event Type
    Other
    Date Received
    April 6, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 7, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE REVOLUTION PUMP HEAD. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). THE CUSTOM PERFUSION PACK IS NOT SOLD IN THE UNITED STATES. HOWEVER, THE REVOLUTION PUMP HEAD IS DISTRIBUTED IN THE UNITED STATES. THE 510(K) NUMBER FOR THE REVOLUTION PUMP HEAD IS K030462. SORIN GROUP (B)(4) RECEIVED A REPORT OF NOISE COMING FROM THE CENTRIFUGAL PUMP AN INCREASE IN THE TEMPERATURE OF THE REVOLUTION PUMP HEAD DURING A CASE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE ISSUE OCCURRED AT THE END OF THE PROCEDURE. IT WAS ALSO REPORTED THAT THE BLOOD WITHIN THE PUMP HEAD APPEARED TO CHANGE COLOR. THE CIRCUIT WAS CHANGED OUT AND THE DEVICE, ALONG WITH THE BLOOD WITHIN THE CIRCUIT, WAS DISCARDED. THE PATIENT WAS GIVEN BANK BLOOD AS A RESULT OF THIS BLOOD LOSS BUT WAS NOT INJURED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF NOISE COMING FROM THE CENTRIFUGAL PUMP AND AN INCREASE IN THE TEMPERATURE OF THE REVOLUTION PUMP HEAD. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP82200 I MIRANDOLA CUSTOMER PERFUSION PACK DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR