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

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG 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
 

CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 09/01/2021
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse events of loss of consciousness and death, which required the emergent discontinuation of hd therapy and initiation of emergency lifesaving measures. The definitive cause of the patients adverse events is unknown; therefore, causality cannot firmly be established. However, per the bmt, the serious adverse events occurred during hd therapy and the 2008t hemodialysis systems uf pump required recalibration. The esrd population continues to have significantly higher mortality (up to 30-fold higher), and fewer expected years of life when compared to the general population. Based on the limited information available, the 2008t hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the patients serious adverse events and subsequent death. At this time there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused and/or contributed to the events. However, given the patient was actively undergoing hd therapy when the events began, and the uf pump required recalibration during post-event testing; this clinical investigation cannot disassociate the device from the serious adverse events. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. ¿.
 
Event Description
Fresenius became aware this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) lost consciousness during hd therapy. It was reported cardiopulmonary resuscitative (cpr) measures were undertaken, however the patient expired. The patients initial reason for admission was a broken femur. No additional information provided during intake. Subsequent attempts to obtain additional clinical information (e. G. , discharge summary, death certificate, autopsy report, esrd death notification, patient demographics, treatment records) have thus far proven unsuccessful. On (b)(6) 2021, a bio-medical technician (bmt) was contacted to perform functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system. A review of the uf problem identification checklist revealed the 2008t hemodialysis system required recalibration of the uf pump. During post-event testing, a uf pump error occurred, and the uf strokes were above the allowable limit at 1. 008 ml/stroke (allowable limits
=
0. 996  1. 004 ml/stroke) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid then what was programmed into the device). The remainder of the validation testing fell within manufacturer specifications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12615846
MDR Text Key275955139
Report Number2937457-2021-02039
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
-
-