BEUDAMED
    FDA Adverse Event Other Summary report: N

    STONYBROOK HSP NY NY 1

    MDR report key: 5088142 · Received September 15, 2015

    Report

    Report Number
    1718850-2015-00343
    Event Type
    Other
    Date Received
    September 15, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    OEZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SETUP THE CLINICIAN FOUND THE OUTLET PORT ON THE ARTERIAL FILTER BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THE INVOLVED ARTERIAL FILTER WITH ATTACHED BYPASS LOOP WAS RETURNED TO SORIN GROUP USA FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THAT OUTLET PORT WAS BROKEN. THE BREAK OCCURRED AT THE BASE OF THE CONNECTION BETWEEN THE TUBING AND THE ARTERIAL FILTER OUTLET CONNECTOR. THERE WAS NO EVIDENCE OF EXCESSIVE SOLVENT ON THE BROKEN PORT. ROOT CAUSE INVESTIGATION HAS DETERMINED THAT THIS ISSUE IS MOST LIKELY A RESULT OF INTERNAL STRESS WHICH CAN BE EMPHASIZED BY THE SOLVENT USED TO BOND THE CONNECTION AND/OR THE ASSEMBLY PROCESS. SORIN GROUP USA HAS OPENED A (B)(4) TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP MANUFACTURES THE CUSTOM PERFUSION PACK. THE ARTERIAL FILTER, CATALOG NUMBER 050527, LOT#14120300090, IS A COMPONENT OF THE PACK. THE 510(K) NUMBER FOR THE ARTERIAL FILTER IS K112525. SORIN GROUP RECEIVED A REPORT THAT DURING SETUP THE CLINICIAN FOUND THE OUTLET PORT ON THE ARTERIAL FILTER BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SETUP THE CLINICIAN FOUND THE OUTLET PORT ON THE ARTERIAL FILTER BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608093 STONYBROOK HSP NY NY 1 CUSTOM PERFUSION PACK OEZ SORIN GROUP USA, INC. NA 1508200026

    Patients

    Seq Age Sex Outcome Treatment
    1