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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Hypoxia (1918)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between crrt utilizing the ultraflux av 600 s dialyzer and the patient¿s dialyzer reaction, characterized by dyspnea.It is well documented that patients on modalities of dialysis may experience reactions involving non-biocompatibility due to the composition of dialyzer membranes of various types of dialyzers.Typically, the onset of a dialyzer reaction presents 30 minutes after initiation of treatment and may include symptoms of dyspnea.The fresenius ultraflux av 600 s dialyzer instructions for use states in rare cases, hypersensitivity reactions may occur during acute dialysis treatment.In severe cases, dialysis must be discontinued and the appropriate medication initiated.In the absence of a documented dialyzer product investigation and the required information concerning this patient and event, the root cause of the patient¿s dyspnea cannot be determined at this time.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 a hospitalized patient on continuous renal replacement therapy (crrt) experienced shortness of breath during crrt while utilizing the ultraflux av 600 s dialyzer.The patient was in a hemodialysis room to receive their crrt treatment.They were given intravenous (iv) 0.9% sodium chloride at 2000 ml and dexamethasone sodium phosphate (dosage unknown) injection prior to the crrt treatment.Approximately 30 minutes following the initiation of treatment, the patient felt dyspneic.The patient¿s blood pressure was 120/70 mmhg and oxygen saturation presented 76%.The treatment was stopped immediately, and the patient was given an iv push of dexamethasone sodium phosphate at 5 mg.Approximately 15 minutes following dexamethasone administration, the patient¿s blood pressure presented 150/72 mmhg and oxygen saturation slowly returned to 92%.This event was reported to the patient¿s physician.It was reported the patient recovered from this event; however, it is unknown if the patient was able to complete the treatment.Multiple attempts were made to obtain additional information, and thus far, no further details have been provided.

Event Description

It was reported that a hospitalized patient on continuous renal replacement therapy (crrt) experienced shortness of breath during crrt while utilizing the ultraflux av 600 s dialyzer.The patient was in a hemodialysis room to receive their crrt treatment.They were given intravenous (iv) 0.9% sodium chloride at 2000 ml and dexamethasone sodium phosphate (dosage unknown) injection prior to the crrt treatment.Approximately 30 minutes following the initiation of treatment, the patient felt dyspneic.The patient¿s blood pressure was 120/70 mmhg and oxygen saturation presented 76%.The treatment was stopped immediately, and the patient was given an iv push of dexamethasone sodium phosphate at 5 mg.Approximately 15 minutes following dexamethasone administration, the patient¿s blood pressure presented 150/72 mmhg and oxygen saturation slowly returned to 92%.This event was reported to the patient¿s physician.It was reported the patient recovered from this event; however, it is unknown if the patient was able to complete the treatment.Multiple attempts were made to obtain additional information, and thus far, no further details have been provided.

Manufacturer Narrative

Plant investigation: the reported complaint could not be confirmed as the complaint device was not returned for manufacturer evaluation.A review of the instructions for use (ifu) determined that the described situation is adequately addressed.Due to 100% testing, it is highly unlikely to detect a failure in any retention sample.Furthermore, only a small number of reserve samples are available.Therefore, a retention sample analysis was not performed.For similar cases in the past, extraction of retention samples showed no unusual residuals which could lead to the reported reaction.Therefore, it is assumed that the patient allergy/reaction might have been caused by other factors besides the dialyzer, for example, the specific physical/medical status of the patient.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was 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 lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• 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 str. 6-8; st. wendel 66606 ; GM 66606
• MDR Report Key: 11142884
• MDR Text Key: 226006853
• Report Number: 3002807005-2021-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5007361
• Device Lot Number: A2BD01200
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention