BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 5442402 · Received February 17, 2016

    Report

    Report Number
    3006158088-2016-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 21, 2016
    Manufacturer
    SMISSON-CARTLEDGE BIOMEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K052055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6) ON (B)(6) 2016. THE HOSPITAL REPORTED THAT A PATIENT WITH A GI BLEED WAS BEING TRANSPORTED BY AMBULANCE TO THE ER DEPARTMENT. UPON ARRIVAL, THE TIS-1200 UNIT WAS SET-UP WITH A PTC-1200 (CASSETTE WITH PATIENT LINE AND 3 SPIKE SET). AFTER SET UP, THE ER STAFF HAD A LEAK AT THE TOP OF 3 SPIKE SET RESERVOIR RESULTING IN ~800ML OF BLOOD SPILLED. THE NURSE EDUCATOR WAS CONTACTED AND NOTICED NO VENT FILTER WAS ON THE 3 SPIKE SET RESERVOIR. THE NURSE EDUCATOR ATTACHED A CAP ALLOWING THE 3 SPIKE SET TO BE USED WITHOUT REPLACEMENT BUT THE PROCESS TOOK ABOUT 15-20 MINUTES. THE 3 SPIKE SET WAS NOT RETAINED BY THE HOSPITAL FOR FURTHER INVESTIGATION; HOWEVER, A PHOTO OF THE TUBING SET WAS PROVIDED. PTC-1200 RETAINS WERE PROFILED FOR A MISSING VENT FILTER AND NO ISSUES WERE FOUND WITH THE TUBING SETS. THE MANUFACTURER INSPECTED ALL PRODUCT AT THEIR FACILITY AND NO MISSING VENT FILTERS WERE NOTED. ALL INVENTORY WAS REVIEWED AT THE HOSPITAL AND NO 3 SPIKE SET MISSING THE HYDROPHOBIC VENT FILTER WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99133 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 302272

    Patients

    Seq Age Sex Outcome Treatment
    1