BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHILDRENS MERCY KS CITY MO1

    MDR report key: 1802690 · Received August 10, 2010

    Report

    Report Number
    1718850-2010-00133
    Event Type
    Other
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 12, 2010
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN. IT WAS NOT PROVIDED BY THE FACILITY. WITHOUT THE LOT NUMBER, THE EXPIRATION DATE IS ALSO UNKNOWN. THE LOT NUMBER IS UNKNOWN. IT WAS NOT PROVIDED BY THE FACILITY. WITHOUT THE LOT NUMBER, THE MANUFACTURING DATE IS ALSO UNKNOWN. SORIN GROUP (B)(4) MANUFACTURES THE CSC14. IT IS A COMPONENT OF THE CUSTOM PERFUSION PACK. THE 510(K) NUMBER IS K012898. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). DURING THE PROCEDURE, THE PERFUSIONIST NOTICED THAT BLOOD WAS LEAKING PAST THE STOPCOCK DIRECTLY INTO THE CARDIOPLEGIA LINE WITHOUT GOING THROUGH THE HEAT EXCHANGER. DUE TO THE PLACEMENT OF THE TEMPERATURE PROBE ABOVE THE STOPCOCK, THE CARDIOPLEGIA APPEARED COLDER THAN IT ACTUALLY WAS. THE PERFUSIONIST EXPERIENCED DIFFICULTY KEEPING THE HEAT ARRESTED. THE FACILITY DID NOT SAVE AND RETURN THE PRODUCT FOR EVALUATION. ANOTHER UNIT FROM THE SAME LOT WAS LEAK TESTED USING DYE TO VISUALLY OBSERVE THE FLUID PATH FOR LEAKS. NO LEAKS WERE OBSERVED BYPASSING THE STOPCOCK AND NO DYE WAS SEEN EXITING THE OUTLET PORT WITHOUT FIRST PASSING THROUGH THE HEAT EXCHANGER. THE SAMPLE UNIT WAS THEN TESTED FOR HEAT EXCHANGE EFFICIENCY AND FOUND TO MEET SPECIFICATION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. WITHOUT THE PHYSICAL DEVICE, THE ROOT CAUSE FOR THE REPORTED PROBLEM CANNOT BE DETERMINED. SORIN GROUP (B)(4) CONCLUDED THAT THE DIFFICULTY IN ARRESTING THE HEART COULD HAVE BEEN A RESULT OF OTHER CAUSES SUCH AS THE COMPOSITION OF THE CARDIOPLEGIA SOLUTION OR THE CLAMP USED TO INTERMITTENTLY ADMINISTER THE SOLUTION. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PERFUSIONIST NOTICED THAT BLOOD WAS LEAKING PAST THE STOPCOCK DIRECTLY INTO THE CARDIOPLEGIA LINE WITHOUT GOING THROUGH THE HEAT EXCHANGER. THE PERFUSIONIST EXPERIENCED DIFFICULTY IN KEEPING THE HEART ARRESTED. THE PERFUSIONIST STATED THAT THERE WAS NO PATIENT INJURY AND THAT THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHILDRENS MERCY KS CITY MO1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1