• 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 HD SYS. W/O CDX W/BIBAG BLUE STAR 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 HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191130
Device Problem Inadequate Ultra Filtration (1656)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) requested an onsite service evaluation for a fresenius 2008t hemodialysis (hd) machine that was reportedly taking off fluid fast, had fluctuating transmembrane pressure (tmp), and failed the online pressure holding test (pht). A fresenius field service technician (fst) was dispatched to the facility to inspect the 2008t machine. The fst found that valve 36 was failing several times during the valve leak test. The fst also confirmed the machine failed the online pht and had fluctuating tmp. The fst replaced the dialysate pressure transducer to address the fluctuating tmp and ordered a new valve 36 for the facility. Upon follow-up, the fst stated that a nurse from the facility alleged that the machine was ¿taking off fluid too fast¿. The fst confirmed there had been no missed treatments, and the machine was confirmed to be removing the correct amount of fluid from patients. In addition, the fst confirmed the uf pump looked good and did not need calibrating. They also confirmed that valve 36 on the balancing chamber was leaking and the tmp was fluctuating up and down. As previously reported, the fst replaced the dialysate pressure transducer and valve 36. Upon completion of the repair, the machine passed all functional testing and was returned to service. There was no patient injury or harm due to the machine allegedly removing fluid too fast, a failure the fst could not confirm. The replaced parts were available to be returned for evaluation and the fst stated they would be returned via returned goods authorization (rga).
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
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 Key13098363
MDR Text Key284457619
Report Number2937457-2021-02521
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
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
Report Date 01/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191130
Device Catalogue Number191130
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-