BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN GASTRO INTESTINAL

    MDR report key: 14859645 · Received June 29, 2022

    Report

    Report Number
    9612030-2022-03302
    Event Type
    Death
    Date Received
    June 29, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 19, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PLEASE NOTE: PER THE CUSTOMER, NEITHER THE PRODUCT ID NOR LOT NUMBER ARE AVAILABLE. AS A RESULT, THE UDI COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED FROM THE CUSTOMER¿S COMPLAINT REPORT, AND NO PHOTO SAMPLE NOR ACTUAL SAMPLE WITH A LOT NUMBER WAS RECEIVED. A SAMPLE ANALYSIS COULD NOT BE PERFORMED SINCE NO PHOTO SAMPLES NOR ACTUAL SAMPLE DEVICE WAS RECEIVED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT A SAMPLE TO EVALUATE. THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. WITHOUT THE DEVICES, A THOROUGH INVESTIGATION INCLUDING VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. ALTHOUGH THE LOTS ARE UNKNOWN FOR THESE EVENTS, DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR DISTRIBUTION. BASED ON THE PRESENT INFORMATION, AND SINCE NO PHOTO SAMPLE WAS PROVIDED AND NO ACTUAL SAMPLE WAS RECEIVED, A POSSIBLE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED CONDITION COULD NOT BE CONFIRMED NOR RELATED TO A MANUFACTURING PROCESS. EACH LOT OF SALEM SUMP¿ TUBE WITH ANTI-REFLUX VALVE UNDERGOES A VISUAL, FUNCTIONAL, AND DIMENSIONAL TESTING ON AN ACCEPTANCE SAMPLING PLAN. THESE TESTS ARE CONDUCTED IN FINISHED PRODUCT ASSEMBLY AND THE PACKAGING PROCESS. THE INVESTIGATION WAS CONDUCTED WITH A MULTIFUNCTIONAL TEAM, AND THE FINDINGS WERE THAT ALL PROCESSES AND CONTROLS WERE FOUND TO BE FOLLOWED ACCORDING TO PROCEDURE, INCLUDING PACKAGING AND ALL INSPECTIONS PERFORMED ON THE PRODUCT. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. AS CONTROL PROCESS AND ACCORDING TO PROCEDURE FOR INSPECTION STANDARDS FOR THE SALEM SUMP CATHETERS, VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTIONS ARE PERFORMED FOR EACH LOT PRIOR TO PRODUCT RELEASE. AS PART OF THE CONTAINMENT, A NOTIFICATION WAS MADE TO THE PRODUCTION PERSONNEL TO HEIGHTEN AWARENESS OF THE CONDITION REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIGESTIVE SURGERY POST-OPERATIVE PERITONITIS BY PERFORATION OF THE CECUM. 3 DAYS AFTER SURGERY, THE PATIENT HAD ACUTE RESPIRATORY DISTRESS, LEADING THE PATIENT TO BE PLACED IN INTENSIVE CARE, AND REQUIRING INTUBATION ON THE SECOND DAY. MULTI-ORGAN FAILURE TABLE. THE ETIOLOGY WAS RETAINED WHICH SHOWED INHALATION OF GASTRIC FLUID, WHILE THE PATIENT HAD A SALEM PROBE IN ASPIRATION. IT WAS LIKELY A MALFUNCTION OF THE SALEM PROBE. THE NURSING TEAM VISUALIZED THE INHALATION IN DIGESTIVE SURGERY. THE DECEASED FEMALE PATIENT WAS BORN IN (B)(6). THE PHARMACIST DOES NOT KNOW THE REFERENCE OF THE SALEM PROBE, THE SIZE OF THE PROBE AND THE PROBE CONCERNED BY THIS EVENT HAS BEEN DISCARDED. THE PHARMACIST SPECIFIES THAT THEY ORGANIZED A CREX MEETING AND DECIDED TO CHANGE PROVIDER AND WRITE A CARE PROTOCOL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR DIGESTIVE SURGERY POST-OPERATIVE PERITONITIS BY PERFORATION OF THE CECUM. 3 DAYS AFTER SURGERY, THE PATIENT HAD ACUTE RESPIRATORY DISTRESS, LEADING THE PATIENT TO BE PLACED IN INTENSIVE CARE, AND REQUIRING INTUBATION ON THE SECOND DAY. MULTI-ORGAN FAILURE TABLE. ETIOLOGY RETAINED: INHALATION OF GASTRIC FLUID, WHILE THE PATIENT HAD A SALEM PROBE IN ASPIRATION. IT WAS LIKELY A MALFUNCTION OF THE SALEM PROBE. THE NURSING TEAM VISUALIZED THE INHALATION IN DIGESTIVE SURGERY. THE DECEASED FEMALE PATIENT WAS BORN IN 1955. THE PHARMACIST DOES NOT KNOW THE REFERENCE OF THE SALEM PROBE, THE SIZE OF THE PROBE AND THE PROBE CONCERNED BY THIS EVENT HAS BEEN DISCARDED. THE PHARMACIST SPECIFIES THAT THEY ORGANIZED A CREX MEETING AND DECIDED TO CHANGE PROVIDER AND WRITE A CARE PROTOCOL. PER ADDITIONAL INFORMATION RECEIVED ON 13JUL2022, THE DATE OF EVENT INVOLVING THE DEVICE WAS 14MAY2022. THE DEVICE WAS MONITORED EVERY 4 HOURS IN VISCERAL SURGERY AND IN INTENSIVE CARE. ON (B)(6) 2022, THE PATIENT EXPERIENCED PERITONITIS/VOLVULUS OF RIGHT COLON. THERE WAS A RIGHT ILEOCOLECTOMY. ON (B)(6) 2022, THE PATIENT EXPERIENCED ACUTE RESPIRATORY DISTRESS: GROUND GLASS IN BOTH LUNG FIELDS, INHALATION OF GASTRIC FLUID, DECOMPENSATION OF AN IPD AND A REFRACTORY HYPOXEMIA LEADING TO THE PATIENT'S DEATH ON (B)(6) 2022. THERE WAS NO MODEL OR BATCH NUMBER FOR THE DEVICE AVAILABLE IN THE PATIENT'S FILE. PER ADDITIONAL INFORMATION RECEIVED ON 01AUG2022, "IPD" STAND FOR DIFFUSE INTERSTITIAL PNEUMOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957773 UNKNOWN GASTRO INTESTINAL TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH UNKNOWN GI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death