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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 Leak (1250)
Patient Problem Chest Pain (1776)
Event Date 01/11/2022
Event Type  Injury  
Event Description
It was reported to fresenius that a patient on continuous renal replacement therapy (crrt) utilizing the ultraflux av 600s dialyzer experienced chest tightness 5 minutes into treatment due to a reaction of the dialyzer. The reason the patient was on crrt was not provided and it was unknown if this particular treatment was on an inpatient or outpatient basis. Following these symptoms, the patient was given methylprednisolone (unknown route and dose) and their chest distress was alleviated. Approximately 5 ml of blood loss was noted. There was no indication the patient was hospitalized for the event as they were able to undergo subsequent crrt treatments utilizing the same prescription and model of dialyzer without incident. The patient recovered from the dialyzer reaction and is reportedly doing well. It was stated by the patient¿s physician that the event was probably not due to a deficiency or malfunction of any fresenius product(s) or device(s). The patient was not required to continue any modality of renal replacement therapy following the completion of crrt.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a temporal relationship exists between the use of the ultraflux av 600s dialyzer and the event of a dialyzer reaction, characterized by chest tightness (described as chest distress in the follow up). It is well documented that patients on any modality of hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers. The cause of this adverse event can be attributed to this patient¿s intrinsic physiological response to dialyzer use with no probable indication of fresenius product or device deficiency or malfunction as reported by the patient¿s physician. Additionally, in the ultraflux dialyzer instructions for use, it cautions users of the known risk of hypersensitivity during acute dialysis treatment. Therefore, the ultraflux av 600s can be excluded as a root cause of this adverse event. Based on the available information, there is no allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event.
 
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Brand NameULTRAFLUX AV 600 S
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter strabe 6-8
st. wendel 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 Key15020675
MDR Text Key295953363
Report Number3002807005-2022-00019
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,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5007361
Device Lot NumberA1BL21100
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received06/24/2022
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 Treatment Data
Date Received: 07/14/2022 Patient Sequence Number: 1
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