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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 5007361
Device Problem Fluid/Blood Leak (1250)
Patient Problem Chest Pain (1776)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported to fresenius that a patient on continuous renal replacement therapy (crrt) experienced chest tightness approximately 5 minutes into treatment.The patient¿s symptoms were gradually alleviated by slowing the blood flow rate.The events resulted in the patient losing approximately 10 ml of blood.Subsequent attempts to obtain additional information have thus far proven unsuccessful.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there was no indication of a serious injury, patient death, or other adverse event related to a fresenius or xenios product, and there was no other issue warranting further investigation.Additionally, there was no allegation of an ultraflux av 600 s malfunction or deficiency related to the event.
 
Manufacturer Narrative
Plant investigation: the reported complaint could not be confirmed.The complaint sample was not available for evaluation.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Due to 100% testing, it is highly unlikely to detect a failure in a retention sample.Furthermore, only a small number of reserve samples are available.Therefore, the retention sample analysis was not done.In the past, extraction of retention samples showed no unusual residuals which could lead to the reported failure.Therefore, it is assumed that the patient allergy/reaction may have been caused by other factors besides the dialyzer, for example, the specific physical/medical status of the patient.A batch record investigation was conducted, and all released products were found to be conforming to specifications.No indication for any relationship with the reported failure mode was found during the review.Based on the information available, the cause for the reported failure could not be traced to the device.
 
Event Description
It was reported to fresenius that a patient on continuous renal replacement therapy (crrt) experienced chest tightness approximately 5 minutes into treatment.The patient¿s symptoms were gradually alleviated by slowing the blood flow rate.The events resulted in the patient losing approximately 10 ml of blood.Subsequent attempts to obtain additional information have thus far proven unsuccessful.
 
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Brand Name
ULTRAFLUX AV 600 S
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter str. 6-8
frankfurter strabe 6-8 66606
GM  66606
Manufacturer (Section G)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter strabe 6-8
st. wendel 66606
GM   66606
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15020886
MDR Text Key304700911
Report Number3002807005-2022-00020
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/05/2023
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 Number5007361
Device Lot NumberA1BL21100
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/14/2022
Supplement Dates Manufacturer Received01/03/2023
Supplement Dates FDA Received01/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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