BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET

    MDR report key: 229037 · Received June 18, 1999

    Report

    Report Number
    9680437-1999-00010
    Event Type
    Other
    Date Received
    June 18, 1999
    Date of Event
    May 21, 1999
    Report Date
    May 31, 1999
    Manufacturer
    MEDISYSTEMS
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    5/21/1999 1ST OUTPATIENT TREATMENT. USING ARTERIOVENOUS REDISETS MEDISYSTEM & F-8 FRESENIUS DIALYZER. UPON BLOOD IN CIRCUIT, PT C/O SHORTNESS OF BREATH, SUBSEQUENTLY BECAME CYANOTIC AND PULSELESS. TX WAS TERMINATION AND CPR WAS INITIATED. IV BENADRYL 25MG & IV EPINEPHRINE 1MG. PHYSICIAN PRESENT FELT PT EXPERIENCED AN ANAPHYLACTIC REACTION. PT WAS TRANSPORTED TO HOSP VIA AMBULANCE. NEW PT APPARENTLY EXPERIENCED ANAPHYLACTIC REACTION TO SOME UNIDENTIFIED SOURCE IMMEDIATELY UPON BLOOD IN CIRCUIT. SIMILAR EPISODE DURING 1ST ACUTE TREATMENT AT HOSP ON 5/16/1999. THIS WAS ATTRIBUTED TO ALTHIN ALTRA NOVA 170. TREATMENT WAS 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 USED. PT RECEIVED ANOTHER ACUTE TREATMENT ON 5/9/1999 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. 5/28/1999 PT REQUIRED AN ACUTE HEMODIALYSIS TREATMENT FOR FLUID REMOVAL. BLOODLINES LOT# 8XX2K6 10/1998, DIALYZER FRESENIUS F-8 LOT # 8D11708 MAN/STERILIZATION DATE 4\1998, SALINE MCGAW J9C448, HEPARIN PORK LOT# 128030 PHYSICIAN PRESENT. APPROX 10-12 MINUTES INTO TREATMENT PT 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 IV GIVEN. SYMPTOMS IMPROVED. PHYSICIAN FELT THAT THE PT IS HYPERSENSITIVE TO ETHYLENE OXIDE, THE STERILANT IN BOTH THE DIALYZER AND BLOODLINES. MEDISYSTEMS NOTIFIED OF THE ABOVE. CO REQUESTED SENDING 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 5/25/1999. UNOPENED BLOODLINES LOT#8X22K6- 10/1998 SENT OUT 6/1/1999. WILL NOTIFY FRESENIUS WITH THE ABOVE INFO ON 6/1/1999. TO LET THE CO DETERMINE IF IT WOULD LIKE TO PURSUE ANY INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS UNK 9219K19

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L DIALYZER F-V LOT# 9CU215| NEW LOT# 9219K19 FEB 99| 8X17K11 10/1998