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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191128
Device Problems Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine experienced a saline bag filling error and had high transmembrane pressure (tmp). A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine. Additional details were revealed when the fst arrived onsite. The clinic manager (cm) at the facility explained to the fst that the machine was set up incorrectly and the saline backfill was caused by use error. The cm told the fst that one of the lines was left unclamped. Per the cm, they changed the setup and it resolved the issue. However, the tmp was still high. It was confirmed that this occurred during priming; there was no patient involvement. During testing, the fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem. As a precaution, the fst calibrated the dialysate pressure. They also calibrated the bicarb pump and the concentrate pump. The fst confirmed that the cbe upgrades had been completed on the machine, and that there were no reports of the machine giving any filling programs. The fst said the machine was returned to service upon their departure, and they did not have any knowledge of there being further issues. The saline bag filling error was caused by use error, and this was acknowledged by the reporting facility.
 
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Brand Name2008T HD SYS. W/O CDX 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 Key13873989
MDR Text Key287789369
Report Number2937457-2022-00461
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 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191128
Device Catalogue Number191128
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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