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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Hypoxia (1918)
Event Date 10/29/2020
Event Type  Injury  
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 crrt utilizing the ultraflux av 600 s dialyzer and the patient¿s dialyzer reaction, characterized by dyspnea. It is well documented that patients on modalities of dialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers. Typically, the onset of a dialyzer reaction presents 30 minutes after initiation of treatment and may include symptoms of dyspnea. The fresenius ultraflux av 600 s dialyzer instructions for use states in rare cases, hypersensitivity reactions may occur during acute dialysis treatment. In severe cases, dialysis must be discontinued and the appropriate medication initiated. In the absence of a documented dialyzer product investigation and the required information concerning this patient and event, the root cause of the patient¿s dyspnea cannot be determined at this time. 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 serious adverse events.
 
Event Description
It was reported that a hospitalized patient on continuous renal replacement therapy (crrt) experienced shortness of breath during crrt while utilizing the ultraflux av 600 s dialyzer. The patient was in a hemodialysis room to receive their crrt treatment. They were given intravenous (iv) 0. 9% sodium chloride at 2000 ml and dexamethasone sodium phosphate (dosage unknown) injection prior to the crrt treatment. Approximately 30 minutes following the initiation of treatment, the patient felt dyspneic. The patient¿s blood pressure was 120/70 mmhg and oxygen saturation presented 76%. The treatment was stopped immediately, and the patient was given an iv push of dexamethasone sodium phosphate at 5 mg. Approximately 15 minutes following dexamethasone administration, the patient¿s blood pressure presented 150/72 mmhg and oxygen saturation slowly returned to 92%. This event was reported to the patient¿s physician. It was reported the patient recovered from this event; however, it is unknown if the patient was able to complete the treatment. Multiple attempts were made to obtain additional information, and thus far, no further details have been provided.
 
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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 str. 6-8
st. wendel 66606
GM 66606
Manufacturer (Section G)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter str. 6-8
st. wendel 66606
GM 66606
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11142884
MDR Text Key226006853
Report Number3002807005-2021-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5007361
Device Lot NumberA2BD01200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/12/2021
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: 01/08/2021 Patient Sequence Number: 1
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