BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EHTHYLENE OXIDE STERILANT IN MEDISYSTEMS A/V BLOODLINES

    MDR report key: 228746 · Received June 9, 1999

    Report

    Report Number
    228746
    Event Type
    Injury
    Date Received
    June 9, 1999
    Date of Event
    May 21, 1999
    Report Date
    May 31, 1999
    Manufacturer
    MEDISYSTEMS
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 5/21/99, 1ST OUTPATIENT DIALYSIS TREATMENT USING A/V REDI SETS MEDISYSTEM WITH F-8 FRESENIUS DIALYZER. UPON BLOOD IN CIRCUIT PATIENT C/O SHORTNESS OF BREATH, SUBSEQUENTLY BECAME CYANOTIC AND PULSELESS. TREATMENT TERMINATED. CPR INITIATED, IV BENADRYL 25MG AND IV EPINEPHRINE 1MG. PHYSICIAN PRESENT FELT PATIENT EXPERIENCED AN ANAPHYLACTIC REACTION. PATIENT TRANSPORTED TO HOSP VIA AMBULANCE. NEW PATIENT APPARENTLY EXPERIENCED ANAPHYLACTIC REACTION TO SOME UNIDENTIFIED SOURCE IMMEDIATELY UPON BLOOD IN CIRCUIT. SIMILAR EPISODE DURING 1ST ACUTE TREATMENT AT HOSP ON MAY 16, 1999. THIS IS WHAT IS THOUGHT TO BE ATTRIBUTED TO ALTHIN ALTRA NOVA 170. TREATMENT REINITIATED LATER THAT SAME DAY USING AN F-8 DIALYZER AND MEDISYSTEMS BLOODLINES WITHOUT INCIDENT; HOWEVER, ACUTE NURSE NOT SURE WHICH LOT NUMBER OF BLOODLINES WAS USED. PATIENT RECEIVED ANOTHER ACUTE TREATMENT ON MAY 19, 1999 UTILIZING MEDISYSTEMS BLOODLINES AND F-8 DIALYZER WITHOUT INCIDENT. WHEN GOING OVER ALL TREATMENTS AND OCCURRENCES THE ONLY DIFFERENT IDENTIFYING FACTOR IS THE DIFFERENT TYPE OF IV PRIMING SETS. ON MAY 28, 1999 PATIENT REQUIRED AN ACUTE HEMODIALYSIS TREATMENT FOR FLUID REMOVAL. BLOODLINES LOT# 8X22K6 OCT 98, DIALYZER FRESENIUS F-8 LOT #8D11708 MAN/STERILIZATION DATE 4/98, SALINE MCGAW J9C448, HEPARIN PORK LOT #128030 MANUFACTURER ELKINS SINN. PHYSICIAN PRESENT. APPROX 10-12 MINUTES INTO TREATMENT PATIENT STATED "I DON'T FEEL GOOD," COLOR GRAYISH PALE, VISIBLY SHORT OF BREATH, AND VERY ANXIOUS. BP 240/165, O2 SAT 88%. TREATMENT IMMEDIATELY TERMINATED. IV BENADRYL 25MG AND EPINEPHRINE 1 MG GIVEN. SYMPTOMS IMPROVED. PHYSICIAN FELT THAT PT IS HYPERSENSITIVE TO ETHYLENE OXIDE, THE STERILANT IN BOTH THE DIALYZER AND BLOODLINES. CO REQUESTED THAT FACILITY SEND THE BLOODLINES THAT WERE USED FOR THAT TREATMENT AS WELL AS AN UNOPENED SET WITH THE SAME LOT# TO TEST FOR RESIDUAL LEVELS OF ETHYLENE OXIDE. USED BLOODLINES SENT OUT 5/25/99. UNOPENED BLOODLINES LOT #8X22K6- OCT 98 SENT OUT ON 6/1/99. WILL NOTIFY FRESENIUS WITH THE ABOVE INFORMATION ON 6/1/99 TO LET THEM DETERMINE IF THEY WOULD LIKE TO PURSUE ANY INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EHTHYLENE OXIDE STERILANT IN MEDISYSTEMS A/V BLOODLINES BLOODLINES HEMODIALYSIS FJK MEDISYSTEMS UNK 9219K19

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L