BEUDAMED
    FDA Adverse Event Other Summary report: N

    HCA MW DIV KANSAS CITY MO 1

    MDR report key: 2615822 · Received June 8, 2012

    Report

    Report Number
    1718850-2012-00329
    Event Type
    Other
    Date Received
    June 8, 2012
    Date of Event
    April 6, 2012
    Report Date
    May 11, 2012
    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

    SORIN GROUP (B)(4) MANUFACTURES THE PRIMO2X OXYGENATOR/RESERVOIR SYSTEM. THE PRIMO2X IS A COMPONENT OF THE US CUSTOM PERFUSION PACK. THE 510(K) NUMBER IS K050447. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A REPORT THAT DURING A PROCEDURE, THE VENOUS LINE CAME OFF THE INLET PORT OF THE PRIMO2X RESERVOIR, RESULTING IN BLOOD LOSS. THE LINE WAS REATTACHED TO THE VENOUS PORT AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PT COMPLICATIONS DUE TO THE INCIDENT. AFTER THE PROCEDURE, THE PERFUSIONIST SAID HE NOTICED THERE WAS NO BARB ON THE VENOUS PORT OF THE RESERVOIR. THE DEVICE AND TUBING WAS DISCARDED BY THE HOSP. THE INCIDENT WAS NOT ORIGINALLY REPORTED TO SORIN GROUP. SORIN DID NOT BECOME AWARE OF THIS REPORTED PROBLEM UNTIL A SORIN REP WAS AT THE CUSTOMER SITE DURING A ROUTINE VISIT. UPON REVIEW OF THE HEART LUNG PERFUSION PACK PRINT, IT WAS DETERMINED THAT SORIN GROUP USA DOES NOT PRE-ATTACH THE SMARXT TUBING TO THE VENOUS INLET PORT. THE CONNECTION IS MADE BY THE USER. THE INSTRUCTIONS FOR USE STATE "...PREVENT LEAKS OR TUBING DISCONNECTS BY PUSHING THE PROPER SIZE TUBING AT LEAST 1/4 INCH PAST THE APEX OF THE INNERMOST BARB OF THE CONNECTOR AND TIE WRAP IF APPROPRIATE.".. "AND "SORIN GROUP USA, INC RECOMMENDS TIE BANDING SMARXT TUBING TO ALL BARBED CONNECTORS AND COMPONENT PARTS." WITHOUT ANY PRODUCT AVAILABLE FOR EVAL, IT IS UNK IF THE TUBING HAD BEEN ATTACHED AND TIE BANDED CORRECTLY. THE REPORTED ISSUE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT DURING A PROCEDURE, THE VENOUS LINE CAME OFF THE INLET PORT OF THE OXYGENATOR, RESULTING IN BLOOD LOSS. THE LINE WAS REATTACHED TO THE OXYGENATOR PORT AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PT COMPLICATIONS DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCA MW DIV KANSAS CITY MO 1 CUSTOM PERFUSION PACK DTZ SORIN GROUP USA, INC. NA 1135600035

    Patients

    Seq Age Sex Outcome Treatment
    1