MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5007361

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chest Pain (1776)

Event Date 01/11/2022

Event Type  Injury  

Event Description

It was reported to fresenius that a patient on continuous renal replacement therapy (crrt) utilizing the ultraflux av 600s dialyzer experienced chest tightness 5 minutes into treatment due to a reaction of the dialyzer.The reason the patient was on crrt was not provided and it was unknown if this particular treatment was on an inpatient or outpatient basis.Following these symptoms, the patient was given methylprednisolone (unknown route and dose) and their chest distress was alleviated.Approximately 5 ml of blood loss was noted.There was no indication the patient was hospitalized for the event as they were able to undergo subsequent crrt treatments utilizing the same prescription and model of dialyzer without incident.The patient recovered from the dialyzer reaction and is reportedly doing well.It was stated by the patient¿s physician that the event was probably not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient was not required to continue any modality of renal replacement therapy following the completion of crrt.

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 the use of the ultraflux av 600s dialyzer and the event of a dialyzer reaction, characterized by chest tightness (described as chest distress in the follow up).It is well documented that patients on any modality of hemodialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.The cause of this adverse event can be attributed to this patient¿s intrinsic physiological response to dialyzer use with no probable indication of fresenius product or device deficiency or malfunction as reported by the patient¿s physician.Additionally, in the ultraflux dialyzer instructions for use, it cautions users of the known risk of hypersensitivity during acute dialysis treatment.Therefore, the ultraflux av 600s can be excluded as a root cause of this adverse event.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 adverse event.

Manufacturer Narrative

Plant investigation: the reported complaint could not be confirmed.The complaint sample was not available for evaluation.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Due to 100% testing, it is highly unlikely to detect a failure in a retention sample.Furthermore, only a small number of reserve samples are available.Therefore, the retention sample analysis was not done.In the past, extraction of retention samples showed no unusual residuals which could lead to the reported failure.Therefore, it is assumed that the patient allergy/reaction may have been caused by other factors besides the dialyzer, for example, the specific physical/medical status of the patient.A batch record investigation was conducted, and all released products were found to be conforming to specifications.No indication for any relationship with the reported failure mode was found during the review.Based on the information available, the cause for the reported failure could not be traced to the device.

Event Description

It was reported to fresenius that a patient on continuous renal replacement therapy (crrt) utilizing the ultraflux av 600s dialyzer experienced chest tightness 5 minutes into treatment due to a reaction of the dialyzer.The reason the patient was on crrt was not provided and it was unknown if this particular treatment was on an inpatient or outpatient basis.Following these symptoms, the patient was given methylprednisolone (unknown route and dose) and their chest distress was alleviated.Approximately 5 ml of blood loss was noted.There was no indication the patient was hospitalized for the event as they were able to undergo subsequent crrt treatments utilizing the same prescription and model of dialyzer without incident.The patient recovered from the dialyzer reaction and is reportedly doing well.It was stated by the patient¿s physician that the event was probably not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient was not required to continue any modality of renal replacement therapy following the completion of crrt.

• Brand Name: ULTRAFLUX AV 600 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15020675
• MDR Text Key: 295953363
• Report Number: 3002807005-2022-00019
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5007361
• Device Lot Number: A1BL21100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/03/2023
• 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
• Patient Sex: Female