BEUDAMED
    FDA Adverse Event Other Summary report: N

    CP387312 DE FULDA

    MDR report key: 2543097 · Received March 28, 2012

    Report

    Report Number
    1718850-2012-00021
    Event Type
    Other
    Date Received
    March 28, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 29, 2012
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE COMPACTFLO EVO OXYGENATOR WHICH IS COMPONENT OF THE ITALY CUSTOM PERFUSION PACK. NEITHER THE CUSTOMER PERFUSION PACK NOR THE EVO OXYGENATOR IS SOLD IN THE UNITED STATES. THEREFORE, THERE IS NO 510(K) NUMBER FOR THIS OXYGENATOR. HOWEVER, THE OXYGENATOR HEAT EXCHANGER MODULE IS THE SAME AS USED IN OTHER SORIN OXYGENATORS DISTRIBUTED IN THE UNITED STATES. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER SETTING UP AND PRIMING THE CIRCUIT, OVER 300 ML OF PRIMING FLUID LEAKED FROM THE WATER PORTS OF THE OXYGENATOR. IT WAS REPORTED THAT THE CIRCUIT HAD BEEN PRIMED THE NIGHT BEFORE AND STAYED PRIMED OVER NIGHT. THE LEAKAGE WAS DISCOVERED ABOUT 30 MINUTES AFTER TURNING ON THE PUMP. THIS OCCURRED DURING SETUP. THERE WAS NO PT INVOLVEMENT. THE PRODUCT HAS BEEN RETURNED TO SORIN GROUP (B)(4) FOR EVALUATION. THE INVESTIGATION IS ON-GOING. 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 THAT, AFTER SETTING UP AND PRIMING THE CIRCUIT, OVER 300 ML OF PRIMING FLUID LEAKED FROM THE WATER PORTS OF THE OXYGENATOR. IT WAS REPORTED THAT THE CIRCUIT HAD BEEN PRIMED THE NIGHT BEFORE AND STAYED PRIMED OVER NIGHT. THE LEAKAGE WAS DISCOVERED ABOUT 30 MINUTES AFTER TURNING ON THE PUMP. THE ISSUE WAS DISCOVERED DURING SETUP AND PRIMING, PRIOR TO ANY PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP387312 DE FULDA CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 1111020083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA