BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALDAHOL

    MDR report key: 9121493 · Received September 25, 2019

    Report

    Report Number
    3003690398-2019-00003
    Event Type
    Injury
    Date Received
    September 25, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 25, 2019
    Manufacturer
    DFB TECHNOLOGY, LTD.
    Product Code
    MED
    PMA / PMN Number
    K113015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    02 AUG 2019: DFB NOTIFIED OF 4 PATIENTS (PT1-N FROM MDR 3003690398-2019-00001, PT2-W FROM MDR 3003690398-2019-00002, PT3-C FROM MDR 3003690398-2019-00003, AND PT4-D FROM MDR 3003690398-2019-00004) WHO HAD BEEN HOSPITALIZED OR HAD THEIR HOSPITALIZATION PROLONGED AFTER TESTING POSITIVE FOR ACHROMOBACTER XYLO/DENITRIFICANS AFTER UNDERGOING A BRONCHOSCOPY. SCOPE(S) REPROCESSED IN OER-PRO USING ALDAHOL 1.8 HIGH LEVEL DISINFECTANT (ALDAHOL) AS THE DISINFECTING AGENT. 05 AUG 2019: DFB CONFIRMED WITH THE HOSPITAL THAT THE ALDAHOL WAS USED IN MANNER CONSISTENT WITH INSTRUCTIONS FOR USE (I.E. ALDAHOL IS TESTED PRIOR TO EACH CYCLE USING RECOMMENDED TEST STRIPS AND THAT MAXIMUM REUSE PERIOD FOR THE ALDAHOL IS 14 DAYS). 08 AUG 2019: HOSPITAL PROVIDED RELEVANT ALDAHOL LOT NUMBERS AND ASSOCIATED CHANGE DATES: JUNE 19 LOT #191913, JULY 2 LOT #191947, JULY 16 LOT #191947, JULY 30 LOT #191947. HOSPITAL REPORTED THAT THEY WERE CONDUCTING MICROBIAL TESTING ON THE OER-PRO, VIDEOSCOPES, ADAPTOR, COMPRESSOR, WATER SUPPLY AND DRAINS (AIR EXCHANGES ARE CHECKED ON A REGULAR BASIS AND ROOM MAINTAINS NEGATIVE PRESSURE). HOSPITAL CONFIRMED ALL FOUR PATIENTS WERE IMMUNOCOMPROMISED PRIOR TO THE BRONCHOSCOPY. 12 AUG 2019: DFB REQUESTED MICROCHEM LABORATORY TO CONDUCT MICROBIOLOGICAL TESTING ON RETAINED SAMPLES OF ALDAHOL LOT NUMBER 191947 (ALL FOUR PATIENTS HAD A MINIMUM OF ONE BRONCHOSCOPE WITH THIS LOT) AGAINST A. XYLO/DENITRIFICANS. 22 AUG 2019: INITIAL REPORTER PROVIDED A PRELIMINARY INVESTIGATION SUMMARY OF THE MICROBIAL TESTING ON THE OER-PRO, VIDEOSCOPES, ADAPTOR, COMPRESSOR, WATER SUPPLY AND DRAINS WHICH CONCLUDED, "ACHROMOBACTER WAS NOT ISOLATED FROM ANY CULTURE OF THE MOST LIKELY RESERVOIRS. RESULTS DO NOT EXCLUDE THE POSSIBILITY OF A RESERVOIR OF THE ORGANISM BEING PRESENT IN THE BRONCH LAB." THIS SUMMARY ALSO REPORTED THAT THE SUSCEPTIBILITY PROFILE OF PATIENT PT2-W (SEE MDR 3003690398-2019-00002) ISOLATE WAS RESISTANT TO ALL DRUG CLASSES TESTED WHEREAS THE ISOLATES FROM THE OTHER THREE PATIENTS (PT1-N FROM MDR 3003690398-2019-00001, PT3-C FROM MDR 3003690398-2019-00003, AND PT4-D FROM MDR 3003690398-2019-00004) WERE SIMILAR TO EACH OTHER IN SHOWING SUSCEPTIBILITY TO PIP/TAZO, MEROPENEM, LEVOFLOXACIN, AND TRIM/SULFA. SHE ALSO PROVIDED A PATIENT INFORMATION TABLE WHICH INCLUDED PRE-EXISTING CONDITIONS. 28 AUG 2019: DFB MEDICAL AFFAIRS REVIEWER EVALUATED THE FOUR CASES WITH ACCOMPANYING DOCUMENTATION AND DETERMINED THAT THE FDA WAS TO BE NOTIFIED IN THE FORM OF INITIAL 30-DAY REPORTS PENDING THE RESULTS FROM MICROCHEM LABORATORY. 19 SEP 2019: DFB RECEIVED (B)(6) STUDY REPORT (STUDY IDENTIFICATION NUMBER (B)(4)) SUBSTANCE USING A TIME-KILL PROCEDURE" WHEREIN ALDAHOL LOT # 191947, EXPIRY 01 JAN 2020 AND ACTIVATOR LOT # 271922, EXPIRY 01 AUG 2020, (THE SAME LOT COMBINATIONS USED IN A MINIMUM OF ONE BRONCHOSCOPY FOR EACH PATIENT) WERE INOCULATED WITH M. TERRAE AND A. XYLOSOXIDANS, THEN MIXED AND INCUBATED. REDUCTION OF MICROORGANISMS WERE CALCULATED BY COMPARING INITIAL MICROBIAL CONCENTRATIONS TO FINAL MICROBIAL CONCENTRATIONS. STUDY RESULTS INDICATE THAT FORM. TERRAE, WHICH WAS USED AS A COMPARISON BECAUSE THIS TEST ORGANISM WAS STUDIED IN THE ORIGINAL 510(K) TO DETERMINE DISINFECTION EFFICIENCY, THE ORGANISM DROPPED BELOW THE LIMITS OF DETECTION IN ALL THREE REPLICATES AFTER TWO MINUTES. THE A. XYLOSOXIDANS WAS DRASTICALLY REDUCED AFTER TWO MINUTES, BELOW THE LIMITS OF DETECTION IN ONE REPLICATE, AND BELOW THE LIMITS OF DETECTION IN ALL THREE REPLICATES AFTER TEN MINUTES. ACCORDING TO THE INDICATIONS FOR USE, THE EXPOSURE FOR HIGH-LEVEL DISINFECTION IS 10 MINUTES AT 20°C. BASED ON THESE RESULTS, IT IS CONCLUDED THAT THIS LOT OF ALDAHOL FUNCTIONED AS EXPECTED AND WAS NOT A CONTRIBUTING FACTOR IN THE POSITIVE TEST RESULTS OF A. XYLOSOXIDANS FOR THESE PATIENTS. PLEASE NOTE: THE DELAY IN SENDING INITIAL 30-DAY REPORTS WAS SOLELY DUE TO LOGISTICS OF OBTAINING WEB TRADER PRODUCTION SERVER ACCOUNT ACCESS.

    Description of Event or Problem · 1

    PATIENT ADMITTED AFTER TESTING POSITIVE FOR ACHROMOBACTER XYL DENITRIFICANS FOLLOWING BRONCHOSCOPY. BRONCHOSCOPE HAD BEEN REPROCESSED IN OER-PRO USING ALDAHOL. FACILITY REPORTED THAT A TOTAL OF 70 BRONCHOSCOPIES HAD BEEN PERFORMED IN THE MONTH OF JULY WITH 4 PATIENTS SUBSEQUENTLY TESTING POSITIVE FOR ACHROMOBACTER XYL DENITRIFICANS. HOSPITAL MICROBIOLOGY LAB EVALUATION REPORTED THAT THE ISOLATES FROM THREE PATIENTS (INCLUDING PATIENT DESIGNATED IN THIS REPORT AS PT3-C) WERE SIMILAR TO EACH OTHER SHOWING SUSCEPTIBILITY TO PIP/TAZO, MEROPENEM, LEVOFLOXACIN, AND TRIM/SULFA. THE ISOLATE FROM THE FOURTH PATIENT DIFFERED FROM THE OTHER ISOLATES. CULTURE SAMPLES IN THE BRONCH LAB WERE OBTAINED TO DETERMINE COMMON SOURCE WITH SAMPLES FROM SCOPES' "BRUSH SCRUB AND FLUSH 20 ML PBS" STILL PENDING RESULTS AND ALL OTHER CULTURES NEGATIVE FOR ACHROMOBACTER. PT3-C HAD BRONCHOSCOPE (B)(6) 2019 AS AN OUTPATIENT. SPECIMEN RESULTED POSITIVE FOR THE ACHROMOBACTER AND WAS SUBSEQUENTLY HOSPITALIZED. PREEXISTING CONDITIONS: COPD, CHEST PAIN, DM, AFIB. PROCEDURE: BRONCHOSCOPY (B)(6) 2019. STATUS: OUTPATIENT, ADMITTED POST-BRONCH CULTURE. INITIAL REPORTER FURTHER CLARIFIED THAT ALL FOUR PATIENTS WERE IMMUNOCOMPROMISED PRIOR TO PROCEDURES. ALL PATIENTS SUBSEQUENTLY TREATED AND RELEASED AFTER HAVING EITHER BEEN HOSPITALIZED OR HAVING HOSPITALIZATION EXTENDED DUE TO TESTING POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914988 ALDAHOL HIGH LEVEL DISINFECTANT MED DFB TECHNOLOGY, LTD. 191947

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR