BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHAGENYX

    MDR report key: 21544479 · Received March 7, 2025

    Report

    Report Number
    3014265054-2025-00001
    Event Type
    Death
    Date Received
    March 7, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 21, 2025
    Manufacturer
    PHAGENESIS LTD
    Product Code
    QQG
    UDI-DI
    15060453480004
    PMA / PMN Number
    DEN220025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMPLIANT REFERENCE (B)(4). THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND IS NOT AVAILABLE FOR EVALUATION. SUBMISSION DELAYED DUE TO ESG SET UP. FORM FDA 3500A PDF WAS UPLOADED ONTO WEBTRADER TEST ACCOUNT 27 FEB 2025.

    Additional Manufacturer Narrative · 0

    MANUFACTURER COMPLIANT REFERENCE (B)(4). THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND IS NOT AVAILABLE FOR EVALUATION. SUBMISSION DELAYED DUE TO ESG SET UP. FORM FDA 3500A PDF WAS UPLOADED ONTO WEBTRADER TEST ACCOUNT 27 FEB 2025. ADDITION OF SUPPLEMENTAL FOLLOW UP INFORMATION 21 MAR 2025 UPDATED INFORMATION WAS RECEIVED VIA EMAIL FROM THE REPORTING HOSPITAL, STATING THAT THE TUBE FEED WAS NOT LOCATED IN THE PATIENT LUNGS BUT WAS OBSERVED IN THE UPPER AIRWAYS AND THAT WITHOUT AN AUTOPSY THERE IS NO WAY TO KNOW IF IT WAS IN THE LOWER AIRWAYS. THE UPDATED INFORMATION DOES NOT CHANGE THE OUTCOME OF THIS INVESTIGATION AND IS STILL DEEMED REPORTABLE AS THE DEVICE COULD STILL HAVE LED TO THE PATIENT DEATH. IF FURTHER INFORMATION IS MADE AVAILABLE, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DEATH OF A PATIENT THAT HAD A PHAGENYX PNX-1000 CATHETER IN PLACE, WHILST RECEIVING TUBE FEEDS VIA THE CATHETER. THE HOSPITAL FOLLOWED CORRECT PROCEDURES IN CONFIRMING CORRECT POSITION OF THE TUBE IN THE STOMACH BY X-RAY PRIOR TO INITIATING FEEDING. THE CATHETER HAD NOT BEEN USED TO DELIVER ELECTRICAL STIMULATION. PT WAS IN DIALYSIS, WAS INCONTINENT OF BOWEL AND THEY CLEANED HIM UP. THIS WAS AT THE END OF HIS DIALYSIS RUN. THE PATIENT WAS FULLY ALERT AND ORIENTED WHEN HE WENT TO DIALYSIS, AND THEY NOTED HE BECAME LETHARGIC AFTER CLEANING HIM UP. WHEN THEY TOOK HIM BACK TO PCU THEY IMMEDIATELY CALLED A RAPID RESPONSE AND THEN A CODE BLUE. TUBE FEEDS STOPPED PRIOR TO STARTING COMPRESSIONS. WHEN THEY WERE INTUBATING HIM, THEY FOUND TUBE FEEDING IN HIS LUNGS, PHYSICIANS REPORTED THAT THE PATIENT MAY HAVE ASPIRATED TUBE FEEDS. THERE IF NO DIRECT EVIDENCE THAT THE TUBE ENTERED THE AIRWAYS ONLY THAT FEED WAS FOUND IN THE AIRWAYS. CAUSE OF DEATH HAS NOT YET BEEN COMMUNICATED BY THE HOSPITAL TO THE MANUFACTURER. THE CATHETER WAS DICARDED. THERE IS CURRENTLY NO EVIDENCE OF ANY DEFECT OR FAULT WITH THE DEVICE USED, AND NO CASUAL RELATIONSHIP BETWEEN THE DEATH AND DEVICE HAS CURRENTLY BEEN ESTABLISHED. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL TO CONFIRM THE CAUSE OF DEATH AND ANY CONTRIBUTORY EFFECT THAT THE DEVICE MAY HAVE HAD.

    Description of Event or Problem · 0

    DEATH OF A PATIENT THAT HAD A PHAGENYX PNX-1000 CATHETER IN PLACE, WHILST RECEIVING TUBE FEEDS VIA THE CATHETER. THE HOSPITAL FOLLOWED CORRECT PROCEDURES IN CONFIRMING CORRECT POSITION OF THE TUBE IN THE STOMACH BY X-RAY PRIOR TO INITIATING FEEDING. THE CATHETER HAD NOT BEEN USED TO DELIVER ELECTRICAL STIMULATION. PT WAS IN DIALYSIS, WAS INCONTINENT OF BOWEL AND THEY CLEANED HIM UP. THIS WAS AT THE END OF HIS DIALYSIS RUN. THE PATIENT WAS FULLY ALERT AND ORIENTED WHEN HE WENT TO DIALYSIS, AND THEY NOTED HE BECAME LETHARGIC AFTER CLEANING HIM UP. WHEN THEY TOOK HIM BACK TO PCU THEY IMMEDIATELY CALLED A RAPID RESPONSE AND THEN A CODE BLUE. TUBE FEEDS STOPPED PRIOR TO STARTING COMPRESSIONS. WHEN THEY WERE INTUBATING HIM, THEY FOUND TUBE FEEDING IN HIS LUNGS, PHYSICIANS REPORTED THAT THE PATIENT MAY HAVE ASPIRATED TUBE FEEDS. THERE IF NO DIRECT EVIDENCE THAT THE TUBE ENTERED THE AIRWAYS ONLY THAT FEED WAS FOUND IN THE AIRWAYS. CAUSE OF DEATH HAS NOT YET BEEN COMMUNICATED BY THE HOSPITAL TO THE MANUFACTURER. THE CATHETER WAS DISCARDED. THERE IS CURRENTLY NO EVIDENCE OF ANY DEFECT OR FAULT WITH THE DEVICE USED, AND NO CASUAL RELATIONSHIP BETWEEN THE DEATH AND DEVICE HAS CURRENTLY BEEN ESTABLISHED. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL TO CONFIRM THE CAUSE OF DEATH AND ANY CONTRIBUTORY EFFECT THAT THE DEVICE MAY HAVE HAD. UPDATED INFORMATION 21 MAR 2025. UPDATED INFORMATION WAS RECEIVED VIA EMAIL FROM THE REPORTING HOSPITAL, STATING THAT THE TUBE FEED WAS NOT LOCATED IN THE PATIENT LUNGS BUT WAS OBSERVED IN THE UPPER AIRWAYS AND THAT WITHOUT AN AUTOPSY THERE IS NO WAY TO KNOW IF IT WAS IN THE LOWER AIRWAYS. THE UPDATED INFORMATION DOES NOT CHANGE THE OUTCOME OF THIS INVESTIGATION AND IS STILL DEEMED REPORTABLE AS THE DEVICE COULD STILL HAVE LED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594068 PHAGENYX OROPHARYNGEAL ELECTRICAL STIMULATOR QQG PHAGENESIS LTD PNX-1000 12649771 15060453480004

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death