• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 1000 S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAFLUX AV 1000 S
Type of DeviceDIALYZER, 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 Key11839228
MDR Text Key265580880
Report Number3002807005-2021-00012
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EUA200149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number01-8981-0
Device Lot NumberB2BE30200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/19/2021
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 Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
-
-