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

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.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.The described situation is adequately addressed in the ifu and/or on the product label.The investigation of the device history records (dhr) found no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The entire lot met release criteria.It is suspected that the reaction was related to the specific physiology of the patient.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Manufacturer Narrative

The plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.

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.It was later reported that the patient was utilizing the fresenius f40s steam sterilized dialyzer, not the f40 hemoflow dialyzer.The lot number for the device was provided.

• Brand Name: F40S STEAM STERILIZED DIALYZER
• Type of Device: DIALYZER, 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
• MDR Report Key: 10095074
• MDR Text Key: 195387200
• Report Number: 1713747-2020-00207
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K921134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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 Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0500714S
• Device Lot Number: Y2BH30102
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 5008 CORDIAX MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR