BEUDAMED
    FDA Adverse Event Other Summary report: N

    YALE NH TT VISION SYS GBS

    MDR report key: 1923310 · Received December 3, 2010

    Report

    Report Number
    1718850-2010-00168
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 9, 2010
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    OEZ
    PMA / PMN Number
    K030716
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDSHELL VENOUS RESERVOIR IS A COMPONENT OF THE (B)(4) HEART LUNG PACK. THE 510K NUMBER FOR THE RESERVOIR IS K030726. THE RESERVOIR WAS MANUFACTURED BY (B)(4). IN (B)(4) 2010, SORIN GROUP USA ACQUIRED (B)(4). THE PERFUSIONIST REPORTED THAT THERE WAS INADEQUATE FLOW THROUGH THE RESERVOIR. THE RESERVOIR WAS CHANGED OUT AND THE PROCEDURE CONTINUED W/O ISSUE. AFTER THE CASE, THE PERFUSIONIST NOTICED A WHITE CAP LODGED IN THE VENOUS INLET PORT OF THE RESERVOIR. SORIN REC'D A REPORT THAT THE PT BECAME HYPOTENSIVE DURING THE CASE. COUNSEL FOR THE HOSPITAL WAS CONTACTED AND STATED THAT THE PT IS FINE, NO COMPLICATIONS. NO ADD'L MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT. THE RESERVOIR WAS RETURNED TO SORIN FOR EVAL. VISUAL INSPECTION CONFIRMED THE PRESENCE OF A SMALL WHITE OBJECT IN THE VENOUS INLET DOWN TUBE. TESTING SHOWED THAT THE OBJECT IN THE INLET INHIBITED FLOW INTO THE RESERVOIR BUT DID NOT BLOCK THE PORT COMPLETELY. AUTOPSY REVEALED THAT THE OBJECT WAS A WHITE LUER CAP SIMILAR TO CAPS USED ON PORTS LOCATED ON TOP OF THE RESERVOIR. IT IS UNK AS TO HOW THE CAP BECAME LODGED IN THE VENOUS INLET. IT APPEARS TO BE THE RESULT OF A MFG DEFECT. (B)(4) MFG OPERATIONS HAVE BEEN DISCONTINUED. NO ADD'L PRODUCT WILL BE PRODUCED BY (B)(4).

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YALE NH TT VISION SYS GBS HEART LUNG PACK OEZ GISH BIOMEDICAL, INC. 207031

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other