BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODMAN CLAMP 31

    MDR report key: 488451 · Received October 14, 2003

    Report

    Report Number
    MW1029739
    Event Type
    Death
    Date Received
    October 14, 2003
    Date of Event
    September 14, 2003
    Report Date
    October 6, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GDJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P REPAIR OF LARGE CONGENITAL DIAPHRAGMATIC HERNIA AND SIGNIFICANT PULMONARY HYPERTENSION REQUIRING MAXIMAL RESPIRATORY AND PULMONARY SUPPORT THROUGH ECMO. A CIRCUIT LEAK OCCURRED DURING CHANGING OF TUBING ON THE HEAT EXCHANGER WHILE USING A CODMAN CLAMP 31, PART #19-8010 MANUFACTURED BY JOHNSON AND JOHNSON COMPANY. THE PT SUFFERED A CARDIAC ARREST SECONDARY TO A CRITICAL LOSS OF BLOOD VOLUME. A DECISION WAS MADE TO REMOVE PT FROM ADVANCED LIFE SUPPORT SECONDARY TO MULTI-ORGAN FAILURE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/23/04: THE RISK MANAGEMENT PERSON AT THE HOSP ADVISED MFR THAT THE DIRECT CAUSE OF THE EVENT WAS NOT RELATED TO THE DEVICE ITSELF. THE RISK MANAGER NOTED THAT IT IS THE HOSPITAL'S POLICY TO REPORT THIS TYPE OF INFO TO MANUFACTURERS IN ORDER TO ASCERTAIN WHETHER OR NOT SIMILAR REPORTS HAD BEEN RECEIVED. PHYSICAL TESTING WAS NOT POSSIBLE AS THE DEVICE WAS DISCARDED BY THE HOSP. THIS WAS REPORTED TO MFR IN ITS CONVERSATION WITH THE RISK MANAGEMENT DEPT AT THE HOSP. NO LOT INFO WAS AVAILABLE, AND THUS, NO EXAM OF LOT HISTORY RECORDS COULD BE CARRIED OUT. NO FURTHER EVAL OF THE INCIDENT COULD BE UNDERTAKEN, ALTHOUGH THE SITUATION ENCOUNTERED WAS REVIEWED WITH HOSP RISK MANAGEMENT. THE INFO PRESENTED SUGGESTED THAT THE CLAMP USED DID NOT SUFFICIENTLY CLOSE OFF THE TUBING, ALLOWING SOME LEAKAGE OF BLOOD, ALTHOUGH NOT THE PROXIMATE CAUSE OF THE PT'S DEATH. THE AUTOPSY REPORT WAS NOT REQUESTED AS THE DESCRIPTION OF THE EVENT IDENTIFIES THE PRIMARY AND SECONDARY CAUSES OF DEATH (BLOOD LOSS WITH SUBSEQUENT CARDIAC ARREST). PT WAS REMOVED FROM ADVANCED LIFE SUPPORT SECONDARY TO MULTI-ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN CLAMP 31 CLAMP GDJ CODMAN & SHURTLEFF, INC. 19-8010 *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DAY Death