BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMISSON-CARTLEDGE BIOMEDICAL, LLC

    MDR report key: 5400676 · Received January 30, 2016

    Report

    Report Number
    3006158088-2015-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2016
    Date of Event
    December 30, 2015
    Report Date
    January 7, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED "DATE OF THIS REPORT" FROM (B)(6) 2015 TO (B)(6) 2016.

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6), ON (B)(6) 2015. THE HOSPITAL REPORTED THAT THE HYDROPHOBIC FILTER ON THE 3 SPIKE SET WAS MISSING AND WENT UNNOTICED WHEN THE TUBING SET WAS ATTACHED TO THE UNIT. WHEN THE INFUSION STARTED, BLOOD BEGAN LEAKING OUT OF THE PORT ONTO THE THERMACOR 1200 UNIT. PRESSURE BAGS WERE USED IN THE PLACE OF THE DEVICE, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. THE HOSPITAL BIOMED CLEANED THE UNIT; HOWEVER, THE UNIT WAS RETURNED FOR FURTHER CLEANING AND INSPECTION. THE 3 SPIKE SET WAS NOT RETAINED BY THE HOSPITAL FOR FURTHER INVESTIGATION. THE HOSPITAL COULD NOT PROVIDE THE LOT NUMBER FOR THE 3 SPIKE SET; HOWEVER, IT IS BELIEVED THAT LOT 302375 WAS BEING USED. RETAINS WERE PROFILED AND NO ISSUES WERE SEEN WITH THE TUBING SETS. INVENTORY WAS REVIEWED AT THE HOSPITAL AND NO ISSUES WERE SEEN WITH THE 3 SPIKE SET MISSING THE HYDROPHOBIC FILTER.

    Description of Event or Problem · 1

    THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6) HOSPITAL AND MEDICAL CENTER IN (B)(6), ON (B)(6) 2015. THE HOSPITAL REPORTED THAT THE HYDROPHOBIC FILTER ON THE 3 SPIKE SET WAS MISSING AND WENT UNNOTICED WHEN THE TUBING SET WAS ATTACHED TO THE UNIT. WHEN THE INFUSION STARTED, BLOOD BEGAN LEAKING OUT OF THE PORT ONTO THE THERMACOR 1200 UNIT. PRESSURE BAGS WERE USED IN THE PLACE OF THE DEVICE, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. THE HOSPITAL BIOMED CLEANED THE UNIT; HOWEVER, THE UNIT WAS RETURNED FOR FURTHER CLEANING AND INSPECTION. THE 3 SPIKE SET WAS NOT RETAINED BY THE HOSPITAL FOR FURTHER INVESTIGATION. THE HOSPITAL COULD NOT PROVIDE THE LOT NUMBER FOR THE 3 SPIKE SET; HOWEVER, IT IS BELIEVED THAT LOT 302375 WAS BEING USED. RETAINS WERE PROFILED AND NO ISSUES WERE SEEN WITH THE TUBING SETS. INVENTORY WAS REVIEWED AT THE HOSPITAL AND NO ISSUES WERE SEEN WITH THE 3 SPIKE SET MISSING THE HYDROPHOBIC FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58871 SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM FRN SMISSON-CARTLEDGE BIOMEDICAL, LLC PTC-1200 302375

    Patients

    Seq Age Sex Outcome Treatment
    1