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

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.

• Brand Name: UNKNOWN- DIALYZER
• Type of Device: DIALYZER, 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 Key: 11103073
• MDR Text Key: 231123733
• Report Number: 3002807005-2020-00021
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/31/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention