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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH UNKNOWN- DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH UNKNOWN- DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- DIALYZER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Dyspnea (1816); Reaction (2414); Low Oxygen Saturation (2477)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Plant investigation: review of the instructions for use (ifu) and/or device label determined the described situation is adequately addressed. The complaint sample was not available. Due to 100% testing, it is highly unlikely to detect a failure in the retention sample. Furthermore, only a small number of reserve samples are available. Therefore, the retention sample analysis was not performed. The cause for the reported dialyzer reaction could not be confirmed based on the information currently available. In the past, for similar cases, extraction of retained samples showed no unusual residuals which could lead to the reported reaction. Therefore, it is assumed that the patient allergy/reaction was caused by other factors besides the dialyzer, for example, the specific physical/medical status of the patient. A batch record investigation was performed and all product was found to be conforming to specifications, and released without any discrepancies. A cause for the reported event could not be established. Clinical investigation: a temporal relationship exists between the use of the high flux hf80s dialyzer and the event of a dialyzer reaction, characterized by dyspnea, desaturation and chest pain. It is well documented that patients on hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers. The equivalent to the hf80s dialyzer is the optiflux series of dialyzers that are available in the us. In the optiflux instructions for use, it cautions users of the known risk of adverse reactions such as ¿itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest¿. 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 ten minutes into a patient's treatment, a patient experienced a dialyzer reaction involving dyspnea, oxygen desaturation and chest pain. The dialyzer in use was a high flux hf80s dialyzer from batch a2bi28200. The treatment was discontinued, and the patient was disconnected with no return from the blood circuit. Actocortina (hydrocortisone in the us, likely oral administration) at 40mg and supplemental oxygen were administered. The patient recovered and it was decided to change the dialyzer to a sureflux 2 (not a fresenius product). No further information was provided.
 
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Brand NameUNKNOWN- DIALYZER
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 Key11103073
MDR Text Key231123733
Report Number3002807005-2020-00021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN- DIALYZER
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 Received12/08/2020
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: 12/31/2020 Patient Sequence Number: 1
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