MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 1000 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 01-8981-0

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 03/30/2021

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 cvvhd support utilizing the ultraflux av 1000s and the patient¿s death due to chronic cardiac disease.It is well-known that the risk of mortality in hospitalized aki patient is exceptionally high.The patient¿s death due to sudden cardiac death can be attributed to underlying coronary heart disease (chd) and independent of cvvhd support as reported by the patient¿s physician.Considering the patient¿s preexisting critical comorbidities and the statement from the patient's physician, cvvhd support utilizing the ultraflux av 1000s can be excluded as a cause or contributor to this event.It was confirmed this case was not related to the fresenius medical device utilized.Based on the available information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s death.

Event Description

It was reported that a critically ill patient on continuous veno-venous hemodialysis (cvvhd) utilizing the ultraflux av 1000s dialyzer became hypotensive, bradycardic, and hypoxemic during treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device or product.Further review of the complaint intake form revealed the following.The patient was hospitalized on (b)(6) 2021 for an acute kidney injury (aki) and recurrent dyspnea as a result of preexisting, chronic cardiac disease.Pertinent past medical history included recurrent dyspnea for 6 years with a contiguous aggravation for one month prior to hospitalization and chronic severe aortic stenosis with atrial fibrillation and regurgitation (new york heart association class iv).The patient was consensually enrolled into a multicenter study involving the safety and efficacy of the use of cvvhd with an emic2 dialyzer for patients with aki, on (b)(6 2021.The patient was placed on cvvhd utilizing the ultraflux av 1000s on the same day of enrollment into the study.On (b)(6) 2021, through diagnostics and vital signs monitoring in the critical care unit, the patient was found to be severely bradycardic, hypotensive, and hypoxemic.Cardiopulmonary resuscitation was performed, and the patient¿s family was advised the patient¿s prognosis was poor.The decision was made by the patient¿s family to deny advanced cardiac life support, ventilation support or further life saving efforts.As a result, the patient had sudden cardiac death.It was reported the patient¿s cvvhd was discontinued 24 minutes after the patient was found in declining vital signs; however, there was no report the patient¿s death was related to cvvhd or due to a malfunction of any fresenius product or device.The patient¿s physician determined the patient¿s sudden cardiac death may be due to underling disease involving severe, chronic cardiac conditions.Additionally, it was stated the patient¿s death was independent of the relevance of study equipment.

Event Description

It was reported that a critically ill patient on continuous veno-venous hemodialysis (cvvhd) utilizing the ultraflux av 1000s dialyzer became hypotensive, bradycardic, and hypoxemic during treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device or product.Further review of the complaint intake form revealed the following.The patient was hospitalized on 29/mar/2021 for an acute kidney injury (aki) and recurrent dyspnea as a result of preexisting, chronic cardiac disease.Pertinent past medical history included recurrent dyspnea for 6 years with a contiguous aggravation for one month prior to hospitalization and chronic severe aortic stenosis with atrial fibrillation and regurgitation (new york heart association class iv).The patient was consensually enrolled into a multicenter study involving the safety and efficacy of the use of cvvhd with an emic2 dialyzer for patients with aki, on 29/mar/2021.The patient was placed on cvvhd utilizing the ultraflux av 1000s on the same day of enrollment into the study.On 30/mar/2021, through diagnostics and vital signs monitoring in the critical care unit, the patient was found to be severely bradycardic, hypotensive, and hypoxemic.Cardiopulmonary resuscitation was performed, and the patient¿s family was advised the patient¿s prognosis was poor.The decision was made by the patient¿s family to deny advanced cardiac life support, ventilation support or further life saving efforts.As a result, the patient had sudden cardiac death.It was reported the patient¿s cvvhd was discontinued 24 minutes after the patient was found in declining vital signs; however, there was no report the patient¿s death was related to cvvhd or due to a malfunction of any fresenius product or device.The patient¿s physician determined the patient¿s sudden cardiac death may be due to underling disease involving severe, chronic cardiac conditions.Additionally, it was stated the patient¿s death was independent of the relevance of study equipment.

Manufacturer Narrative

Correction: h6; health effect clinical code c50479 was inadvertently omitted from previous submission.

Manufacturer Narrative

Additional information: g1 plant investigation: the reported complaint could not be confirmed.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Furthermore, the complaint sample was not available, and no meaningful pictures were provided.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.In the past, extraction of retention samples showed no unusual residuals which could lead to the reported failure.Additionally, it was determined that the event was related to the patient¿s medical condition.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 that a critically ill patient on continuous veno-venous hemodialysis (cvvhd) utilizing the ultraflux av 1000s dialyzer became hypotensive, bradycardic, and hypoxemic during treatment.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device or product.Further review of the complaint intake form revealed the following.The patient was hospitalized on (b)(6) 2021 for an acute kidney injury (aki) and recurrent dyspnea as a result of preexisting, chronic cardiac disease.Pertinent past medical history included recurrent dyspnea for 6 years with a contiguous aggravation for one month prior to hospitalization and chronic severe aortic stenosis with atrial fibrillation and regurgitation (new york heart association class iv).The patient was consensually enrolled into a multicenter study involving the safety and efficacy of the use of cvvhd with an emic2 dialyzer for patients with aki, on (b)(6) 2021.The patient was placed on cvvhd utilizing the ultraflux av 1000s on the same day of enrollment into the study.On (b)(6) 2021, through diagnostics and vital signs monitoring in the critical care unit, the patient was found to be severely bradycardic, hypotensive, and hypoxemic.Cardiopulmonary resuscitation was performed, and the patient¿s family was advised the patient¿s prognosis was poor.The decision was made by the patient¿s family to deny advanced cardiac life support, ventilation support or further life saving efforts.As a result, the patient had sudden cardiac death.It was reported the patient¿s cvvhd was discontinued 24 minutes after the patient was found in declining vital signs; however, there was no report the patient¿s death was related to cvvhd or due to a malfunction of any fresenius product or device.The patient¿s physician determined the patient¿s sudden cardiac death may be due to underling disease involving severe, chronic cardiac conditions.Additionally, it was stated the patient¿s death was independent of the relevance of study equipment.

• Brand Name: ULTRAFLUX AV 1000 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
• Manufacturer (Section G): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 11839228
• MDR Text Key: 265580880
• Report Number: 3002807005-2021-00012
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01-8981-0
• Device Lot Number: B2BE30200
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/30/2022
• 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): Death
• Patient Sex: Male