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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX EMIC2; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ST. WENDEL AG ULTRAFLUX EMIC2; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 01-9771-0
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/02/2024
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
It was reported to fresenius that a dialyzer blood leak occurred during the patient's continuous renal replacement therapy (crrt) with the ultraflux dialyzer.The reported issue was observed upon treatment initiation.Dialysate was visually observed leaking from the head of the dialyzer.It was confirmed that no leakage was observed during prime.Treatment was discontinued.The patient was reinfused.The patient's estimated blood loss (ebl) is approximately 75 ml.No serious injury or required medical intervention was reported.Treatment was able to continue after the supplies were replaced.The sample was reported to be available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.
 
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Brand Name
ULTRAFLUX EMIC2
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
ST. WENDEL AG
frankfurter str. 6-8
st. wendel 66606
GM  66606
Manufacturer (Section G)
ST. WENDEL AG
frankfurter str. 6-8
st. wendel 66606
GM   66606
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key18731267
MDR Text Key335715770
Report Number3002807005-2024-00005
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number01-9771-0
Device Lot NumberC2BL17100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 02/02/2024
Initial Date FDA Received02/19/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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