MAUDE Adverse Event Report: ST. WENDEL AG DISC. ULTRAFLUX AV 400 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5007341

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Malaise (2359)

Event Date 10/07/2023

Event Type  Injury  

Manufacturer Narrative

Note: a2.The patient's birthyear was reported to fresenius as 1951 without the complete date of birth.The patient's date of birth has been provided as 1951-01-01.Clinical investigation: a temporal relationship exists between hd therapy utilizing the ultraflux av 400 s, and the serious adverse events of an allergic/hypersensitivity reaction (characterized by malaise, dyspnea, desaturation, and hypertension), which required emergent discontinuation of hd therapy and medicinal intervention.The definitive etiology of the events are unknown; therefore, causality cannot be firmly established.However, given the serious adverse events occurred during treatment, the patient¿s previous reaction to the same sterilant, and the patient¿s positive response to the elisio nipro dialyzer, a possible causal and/or contributory role cannot be excluded.Based on the information available, the ultraflux av 400 s cannot be disassociated from the serious adverse events.While uncommon, hypersensitivity reactions are known to occur with the use of the ultraflux av 400 s.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius that this patient with renal failure (rf) on hemodiafiltration (hd) utilizing an ultraflux av 400 s dialyzer for renal replacement therapy (rrt) complained of feeling unwell (malaise) during treatment, and experienced shortness of breath (dyspnea), desaturation, and hypertension.The reported event occurred approximately 9 minutes after the initiation of hd therapy.The patient experienced dyspnea and oxygen desaturation to 82% (oxygen applied, volume/rate unknown).It was determined the patient was having an allergic/hypersensitivity reaction to the ultraflux av 400, and the treatment was abruptly stopped.The patient¿s extracorporeal blood was returned, and they were treated with intravenous (iv) methylprednisolone 40+40+125 mg, chlorpheniramine 20 mg, and subcutaneous (sc) epinephrine 1.0 mg.The patient¿s systolic blood pressure increased to 214 mmhg, and they began to slowly improve over the next 60 minutes.It appears the hd treatment was restarted later the same day; however, the dialyzer type was changed to an elisio nipro dialyzer with good effect.The patient reportedly tolerated the new dialyzer type well and has recovered from the events.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: no parts were returned to the manufacturer.A retention sample analysis was not done.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.In the past for similar cases, extraction of retain samples showed no unusual residuals which could lead to the reported reaction.Therefore, it is assumed that the patient allergy/reaction might be caused by other factors besides dialyzer, for example, the physical/medical status of the patient.A batch record review was performed.It was confirmed that products were inspected according to the inspection protocol and were found to be confirming to specifications.No indication for any relationship with the reported failure mode has been found during the review.The cause of the reported failure cannot be confirmed based on the current available information.

Event Description

It was reported to fresenius that this patient with renal failure (rf) on hemodiafiltration (hd) utilizing an ultraflux av 400 s dialyzer for renal replacement therapy (rrt) complained of feeling unwell (malaise) during treatment, and experienced shortness of breath (dyspnea), desaturation, and hypertension.The reported event occurred approximately 9 minutes after the initiation of hd therapy.The patient experienced dyspnea and oxygen desaturation to 82% (oxygen applied, volume/rate unknown).It was determined the patient was having an allergic/hypersensitivity reaction to the ultraflux av 400, and the treatment was abruptly stopped.The patient¿s extracorporeal blood was returned, and they were treated with intravenous (iv) methylprednisolone 40+40+125 mg, chlorpheniramine 20 mg, and subcutaneous (sc) epinephrine 1.0 mg.The patient¿s systolic blood pressure increased to 214 mmhg, and they began to slowly improve over the next 60 minutes.It appears the hd treatment was restarted later the same day; however, the dialyzer type was changed to an elisio nipro dialyzer with good effect.The patient reportedly tolerated the new dialyzer type well and has recovered from the events.

• Brand Name: DISC. ULTRAFLUX AV 400 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18030186
• MDR Text Key: 326917167
• Report Number: 3002807005-2023-00046
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

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: 5007341
• Device Lot Number: C2BC25200
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2024
• 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
• Treatment: FRESENIUS 5008S HEMODIALYSIS (HD) MACHINE.; FRESENIUS 5008S HEMODIALYSIS (HD) MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG