BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY

    MDR report key: 2846255 · Received November 19, 2012

    Report

    Report Number
    1820334-2012-00526
    Event Type
    Death
    Date Received
    November 19, 2012
    Date of Event
    July 30, 2012
    Report Date
    October 24, 2012
    Manufacturer
    COOK INC
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH UNKNOWN AS NOT PROVIDED BY REPORTER. LOT - UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. DATE USER FACILITY OR IMPORTER BECAME AWARE OF EVENT: LESS THAN OR EQUAL TO 10 DAYS AGO. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN AS LOT IS UNKNOWN. EVENT EVALUATION: PER THE CUSTOMER NO PRODUCT WILL BE RETURNED. QUALITY CONTROL INSURES THAT THE ASSEMBLY WILL WITHSTAND SPECIFIED PRESSURE, PERFORMS TENSILE TEST ON SHAFTS, EXTENSION TUBES AND HUBS. MATERIAL MUST WITHSTAND SPECIFIED LBS FOR EACH BOND AND DISTAL SHAFT. FINAL INSPECTION FOR TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER CONFIRMS CORRECT EXTENSION TUBE WITH WINGED FLLA AND THAT THEY ARE SECURELY ATTACHED. STAMPING ON WINGED FLLA AND EXTENSIONS MUST BE CORRECT AND LEGIBLE. CONFIRM CORRECT CLAMP HAS BEEN USED. THE INSTRUCTIONS FOR USE STATES PRECAUTIONS REGARDING TO IMPEDED LUMEN FLOW AND POWER INJECTION. WE ARE INCONCLUSIVE ON HOW THE DEVICE COULD HAVE CONTRIBUTED TO THE FAILURE MODE. OUR QUALITY CONTROL PERSONNEL COMPLETE AN INCOMING PRESSURE TEST AND CONFIRM CORRECT EXTENSION TUBE WITH WINGED FLLA AND THAT THEY ARE SECURELY ATTACHED. OUR SUPPLIER HAS BEEN CONTACTED DUE TO PRIOR SIMILAR COMPLAINTS. THEY COULD NOT RECREATE THE FAILURE MODE. WE ARE INCONCLUSIVE AS TO WHY THE FAILURE MODE HAPPENED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE CONCLUSION OF QUALITY ENGINEERING RISK ANALYSIS, RISK MITIGATING ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PER MEDWATCH FORM: THERE HAVE BEEN FIVE INSTANCES (1820334-2012-00496, 1820334-2012-00525, 1820334-2012-00526, 1820334-2012-00527, AND 1820334-2012-00532) OF THIS EVENT AND AT LEAST THREE PATIENTS INVOLVED. THE 4 FRENCH DUAL LUMEN PICCS ARE BREAKING AT THE WHITE HUB WITHOUT ANY OBVIOUS REASON. THE CATHETER APPEARS TO BE PULLING OUT OF THE HUB AND THREE OF THESE BREAKS OCCURRED WHEN THE LINE WAS NOT IN USE, THE FIVE INSTANCES OF THIS TYPE OF EVENT HAD THE DEVICE IN PLACE FOR 18 DAYS, 21 DAYS, 42 DAYS, 24 DAYS AND 18 DAYS WHEN THE BREAKS OCCURRED. ALL IN PEDIATRIC PATIENTS. ONE PATIENT IS NON AMBULATORY, ONE PATIENT WAS NON AMBULATORY IN ICU FOR THE MAJORITY OF THE TIME THE LINES WERE IN PLACE, THE OTHER WAS NON AMBULATORY IN ICU FOR THE ENTIRE TIME THE LIENS WERE IN PLACE. NO REPORTED ISSUES WITH TUBING OR LINES BEING PULLED/CAUGHT. FOR ALL CASES, THE PERSON WHO INSERTED THE LINE WAS TRAINED AND CERTIFIED IN THE PROCEDURE (AN INTERVENTIONAL RADIOLOGIST). ALL OF THE PICCS WERE SUTURED IN PLACE AND COVERED WITH A DRESSING. THE LINES ARE FLUSHED WITH A 10 ML-SIZED SYRINGE. THE LINES ARE FLUSHED MINIMUM 3-5 ML. THESE DEVICES AR STORED ON CARTS IN A SUPPLY ROOM. THE CATHETERS ARE IN OPAQUE PACKAGING (STERILE INSERTION TRAY). IN ONE PATIENT, THE LINE WAS REMOVED AND PATIENT COMPLETED TREATMENT WITH PERIPHERAL VASCULAR ACCESS AND REPEATED VENIPUNCTURES FOR LABS. ONE PATIENT REQUIRES ONGOING, CONTINUOUS INFUSION OF VASOACTIVE MEDICATIONS AND SO HAS HAD TO UNDERGO LINE REPLACEMENT 3 TIMES. ADDITIONALLY, ON INCIDENT NECESSITATED HOSPITAL ADMISSION D/T FEVER AND POSITIVE BLOOD CULTURE. PATIENT WAS TREATED WITH ANTIBIOTICS INPATIENT FOR 5 DAYS. ONE PATIENT WAS CRITICALLY ILL THROUGHOUT AND REQUIRED REPLACEMENT OF THE LINE TWICE. PATIENT REQUIRED LINE REPLACEMENT AND HOSPITALIZATION FOR 5 DAYS WITH IV ANTIBIOTICS DUE TO POSITIVE BLOOD CULTURE AT TIME OF BREAK. DISCHARGED HOME WITH NEW PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R