BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO I

    MDR report key: 3724679 · Received February 27, 2014

    Report

    Report Number
    8010042-2014-00063
    Event Type
    Injury
    Date Received
    February 27, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT HAS BEEN TAKEN WITH HE HOSPITAL TO OBTAIN FURTHER INFORMATION SURROUNDING THE EVENT AND TO REQUEST THE RETURN OF THE REMOVED EDI CATHETER FOR INVESTIGATION. THE HOSPITAL HAS PROVIDED PICTURES BUT FURTHER INFORMATION AND THE EDI CATHETER HAS SO FAR NOT BEEN RELEASED. THE VENTILATOR WAS PUT IN SERVICE AFTER DISCONNECTING IT FROM THE PATIENT BUT BEFORE DETECTION OF THE BREAK AND THEREFORE THE HOSPITAL STATED THAT NO VENTILATOR RECORDS WILL BE AVAILABLE. THE PICTURES SHOW THAT THE DISTAL TIP OF THE EDI CATHETER IS MISSING AND THE WIRES ARE EXPOSED. THE WIRES ARE VERY THIN ELECTRODES OF 50UM. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED EDI CATHETER WAS DISCOLORED AND HAD CRACKED WITH ELECTRODE WIRE HANGING BUT ALL WERE INTACT AND NONE WAS MISSING. THE LOWEST PART OF THE CATHETER OF ABOUT 5 CM CONTAINING ALL THE FEEDING HOLES WAS MISSING. THE EVALUATION OF MEDICINES AND NUTRITION THAT WERE ADMINISTERED THROUGH THE EDI CATHETER FOUND NONE OF THEM THAT COULD AFFECT THE MATERIAL OF THE EDI CATHETER. A TEST OF AMIODARONE FOUND THAT IT DOES NOT AFFECT THE MATERIAL OF THE EDI CATHETER. ONE OF THE MEDICINES WAS LISTED AS COULD AFFECT THE PH VALUES IN THE STOMACH BUT IT IS UNKNOWN TO WHAT EXTENT. THE EDI CATHETER MATERIAL PARAMETERS WERE ALL WITHIN THE SPECIFIED LIMITS AND THERE ARE NO OTHER COMPLAINTS RELATED TO THIS BATCH. THIS INVESTIGATION WITH THE INFORMATION AVAILABLE HAS NOT DETERMINED THE TRUE CAUSE OF THE BREAKING OF THE EDI CATHETER BUT THE CAUSE WAS MOST LIKELY DUE TO A COMPLEX COMBINATION OF MATERIAL PROPERTIES AND EFFECTS FROM THE SURROUNDING CHEMICAL AND BIOLOGICAL ENVIRONMENT IN THE STOMACH. THERE WERE NO MANUFACTURING DEFECTS OR OTHER SIMILAR COMPLAINTS FOR THIS BATCH, NO SPECIFIC MEDICINE OR NUTRITION HAS BEEN DETERMINED TO AFFECT THE MATERIAL OF THE EDI CATHETER. THERE IS ALSO NO INDICATION OF MISUSE ALTHOUGH THE EDI CATHETER WAS USED FOR 8 DAYS WHICH IS 3 DAYS MORE THAN THE RECOMMENDED TIME OF USAGE OF 5 DAYS. WHETHER OR NOT THE LONGER USAGE TIME CONTRIBUTED TO THE BREAKAGE HAS NOT BEEN DETERMINED. MAQUET MEDICAL SYSTEMS USA IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CRITICAL CARE (B)(4) (MCC) (MFR).

    Description of Event or Problem · 1

    REF IMPORTER REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122125 SERVO I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1