BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT EDI CATHETER

    MDR report key: 12646345 · Received October 18, 2021

    Report

    Report Number
    8010042-2021-02508
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 18, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    PMA / PMN Number
    K153688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NAVA IS A SUPPORTED MODE OF VENTILATION BASED ON THE ELECTRICAL ACTIVITY OF THE DIAPHRAGM (EDI). NAVA DELIVERS ASSIST IN PROPORTION TO AND SYNCHRONIZED WITH PATIENT BREATHING EFFORTS. IN ORDER FOR NAVA TO BE USED, THE PATIENT MUST HAVE AN ACTIVE RESPIRATORY DRIVE. NAVA REQUIRES THE INSERTION OF AN EDI CATHETER WHICH MONITORS THE EDI IN ALL MODES AND IN STANDBY. THE EDI CATHETER IS A SINGLE-USE FEEDING NG (NASO-GASTRIC) TUBE WITH MEASURING ELECTRODES POSITIONED IN THE ESOPHAGUS SO THAT THE MEASURING ELECTRODES SPAN THE MOVEMENT OF THE DIAPHRAGM. THE SUBJECTED EDI CATHETER WAS IN PLACE FOR LESS THAN 5 DAYS AND WAS DISCARDED BY THE HEALTHCARE FACILITY. NO VENTILATOR LOGS FROM THE CONNECTED VENTILATOR WAS RECEIVED. NO SPECIFIC OBSERVATIONS OR PROBLEMS WERE EXPERIENCED BY THE HEALTHCARE FACILITY DURING POSITIONING OR USE. PROVIDED PICTURES CONFIRMS THE REPORTED EVENT WITH A DAMAGED AND DISCOLOURED TIP OF THE EDI CATHETER. FURTHER INFORMATION FROM THE HEALTHCARE FACILITY STATED THAT THE PATIENT WAS TREATED WITH A SPECIAL DRUG, OXCARBAZEPINE, ORALLY. THE DRUG WAS NOT FLUID ENOUGH SO THE EDI CATHETER WAS BLOCKED. WHEN ADDED PRESSURE, THE EDI CATHETER WAS MOST LIKELY DAMAGED IN THE TIP. THE HEALTHCARE FACILITY HAD EXPERIENCED THE SAME ISSUE WITH A NORMAL FEEDING TUBE. THE FEEDING LUMEN OF THE EDI CATHETER IS SLIGHTLY SMALLER COMPARED TO THE FEEDING LUMEN OF A STANDARD FEEDING TUBE OF THE SAME SIZE. THE REPORTED DISCOLOURISATION IS AN EFFECT FROM THE SURROUNDING CHEMICAL AND BIOLOGICAL ENVIRONMENT IN THE STOMACH AND WILL NOT AFFECT THE PERFORMANCE. THE LOT NO OF THE SUBJECTED EDI CATHETER WAS NOT KNOWN. NO DEVICE HISTORY RECORD REVIEW COULD THEREFORE BE PERFORMED. OUR CONCLUSION WITH THE AVAILABLE INFORMATION IS THAT THERE WAS NO MATERIAL DEFICIENCY. THE BREAKAGE OF THE EDI CATHETER WAS MOST LIKELY THE USE OF A DRUG THAT WAS NOT FLUID ENOUGH AND THE EDI CATHETER TIP THEN BECAME DAMAGED WHEN PRESSURE WAS APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE OF VENTILATION, THE EDI SIGNAL WAS POOR FROM THE EDI CATHETER. AFTER REMOVING THE EDI CATHETER, IT WAS NOTICED THAT IT WAS DAMAGED AND DISCOLOURED IN THE DISTAL AREA. THERE WAS NO PATIENT HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543579 ENFIT EDI CATHETER GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB ENFIT 12FR/125 CM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1