• 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 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 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 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 01/30/2019
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 user facility biomedical technician (biomed) reported a fresenius 2008k2 machine with a flow inlet error during rinse mode.It was confirmed that there was no patient involvement.While inspecting the machine for repair, the biomed reported that the plastic housing of the deaeration motor had melted around the deaeration motor brushed.It was confirmed there was no observed burning smell, smoke, spark, flame, or arcing, and it was confirmed there was no patient involvement.The machine reportedly has 18,345 hours of use on it, and had not had past issued failing the electrical leakage test.The machine is plugged into a gfci outlet.The biomed confirmed he replaced the deaeration motor to resolve the issue and return the machine to service.It was confirmed that photographs of the damage were not available, and confirmed that there were no sample parts available for return.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8347999
MDR Text Key136442903
Report Number2937457-2019-00557
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100859
UDI-Public00840861100859
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age MO
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received02/18/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received03/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-