BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDI CATHETER ENFIT 6FR/49 CM, 5PCS

    MDR report key: 24442008 · Received February 25, 2026

    Report

    Report Number
    8010042-2026-0000280
    Event Type
    Death
    Date Received
    February 25, 2026
    Date of Event
    February 16, 2026
    Report Date
    February 25, 2026
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710015322
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS PERFORMED USING THE INITIAL EVENT DESCRIPTION, ADDITIONAL INFORMATION FROM THE HEALTHCARE FACILITY, X-RAY IMAGES, VENTILATOR LOGS, DHR REVIEW AND LAB ANALYSIS OF THE SUBJECTED EDI CATHETER. THE HEALTHCARE FACILITY REPORTED THAT THE EDI CATHETER WAS IN USE FROM (B)(6) 2026, WHEN A DIAGNOSTIC LAPAROTOMY WAS PERFORMED AND THE EDI CATHETER WAS REMOVED. NO SPECIFIC CLINICAL OBSERVATIONS OR SYMPTOMS WERE REPORTED PRIOR TO THE DETECTION OF THE PERFORATION. ON (B)(6) 2026, AT APPROXIMATELY 5:00 PM, THE FIRST CLINICAL ABNORMALITIES INDICATING PATIENT INSTABILITY WERE OBSERVED. A RADIOLOGICAL EXAMINATION PERFORMED AT 5:47 PM THE SAME DAY CONFIRMED GASTRIC PERFORATION. A DIAGNOSTIC LAPAROTOMY WAS PERFORMED, AND THE PERFORATION SITE WAS SUTURED. DURING SURGERY, NO PENETRATION OF THE EDI CATHETER INTO THE PERITONEAL CAVITY WAS OBSERVED. THE EDI CATHETER WAS VISUALLY INSPECTED BY THE HEALTHCARE FACILITY IMMEDIATELY AFTER REMOVAL, AND NO DEFECTS WERE DETECTED. X-RAY IMAGES WERE PROVIDED BY THE HEALTHCARE FACILITY, WHO RETROSPECTIVELY NOTED THAT THE EDI CATHETER TIP APPEARED TO BE POSITIONED RATHER LOW. GETINGE INTERNAL MEDICINE PROFESSIONAL HAS REVIEWED THE X-RAY IMAGES AND AGREES WITH THIS ASSESSMENT. REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED EDI CATHETER¿S BATCH NUMBER SHOWED THAT ALL PARAMETERS WERE WITHIN THE SPECIFIED LIMITS. VISUAL INSPECTION OF THE RETURNED EDI CATHETER FOUND NO ANOMALIES. IT WAS COMPLETE IN LENGTH WITH NO NOTED DEFECTS. WATER WAS FLUSHED THROUGH THE EDI CATHETER, AND NO LEAKAGE WAS NOTED. THE ELECTRODE ARRAY OF THE TEN BIPOLAR ELECTRODES WAS MEASURED, AND ALL TEN MEASURING POINTS WERE WITHIN SPECIFICATION. THE EDI CATHETER HAS BEEN ABLE TO RECORD DIAPHRAGM ELECTRICAL ACTIVITY AS INTENDED. NO MALFUNCTION OF THE EDI CATHETER HAS BEEN IDENTIFIED AND THERE IS NO INDICATION THAT IT FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS. NEITHER ANY INCORRECT SELECTION OF EDI CATHETER BASED ON PATIENT WEIGHT ACCORDING TO LABELING. THE CAUSE OF THE GASTRIC PERFORATION IS BELIEVED TO BE THE TOO LOW POSITIONING OF THE EDI CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GASTRIC PERFORATION WAS DETECTED IN A PREMATURE INFANT (24+5 WEEKS GESTATION) ON DAY 5 OF LIFE, WHILE RECEIVING HFOV VENTILATION AND EDI MONITORING WITH AN EDI CATHETER. THE INFANT REQUIRED SURGICAL INTERVENTION BUT LATER PASSED AWAY. MANUFACTURER¿S REF #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275417 EDI CATHETER ENFIT 6FR/49 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6893273 3000488975 17325710015322

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Unknown Death