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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. WENDEL AG F40S STEAM STERILIZED DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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ST. WENDEL AG F40S STEAM STERILIZED DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500714S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Itching Sensation (1943); Rash (2033); Malaise (2359)
Event Date 05/08/2020
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: based on the available information, there is a temporal and a likely causal relationship between the fresenius f40 hemoflow dialyzer and the patient¿s reaction (characterized by not feeling well, coughing, chest pain, itchiness, hives, rash, and abdominal pain during the hd treatment). Although rare, hypersensitivity or anaphylactoid reactions to dialyzers are a known risk during hemodialysis. The exposure of the patient¿s blood to a foreign substance present in the extracorporeal circuit is the result of an immunoallergic response. There is no evidence of a f40 hemoflow dialyzer product deficiency or malfunction. Additionally, although the patient experienced an adverse reaction during treatment, there is no allegation of a product malfunction or deficiency related to this event.
 
Event Description
A user facility nurse manager reported that a hemodialysis (hd) patient had a dialyzer reaction during their hd treatment. The reaction required medical intervention and resulted in a dialyzer prescription change. The patient reported not feeling well, was coughing, and complained of chest pain, abdominal pain, and itchiness on the hands and feet. In addition, a hives rash was apparent on their face, torso, hands, and feet. The patient was administered oral cetirizine (dose unknown) which relieved the itch and rash within 45 minutes. The patient slept for the last hour of their 2-hour scheduled treatment, which they reportedly completed. Following the treatment, the patient was switched to another manufacturer¿s dialyzer for future hd treatments. The f40 hemoflow dialyzer that was used for the treatment was reportedly unavailable to be returned for a physical evaluation. Dialyzer lot information and additional patient details were not provided.
 
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Brand NameF40S STEAM STERILIZED DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
ST. WENDEL AG
director, site quality
frankfurter str. 6-8
st. wendel UT 66606
GM 66606
Manufacturer (Section G)
ST. WENDEL AG
director, site quality
frankfurter str. 6-8
st. wendel UT 66606
GM 66606
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10095074
MDR Text Key195387200
Report Number1713747-2020-00207
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K921134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number0500714S
Device Lot NumberY2BH30102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2018
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: 05/28/2020 Patient Sequence Number: 1
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