• 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 OLC ONLY WITH HEPARIN PUMP 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 OLC ONLY WITH HEPARIN PUMP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190628
Device Problem Temperature Problem (3022)
Patient Problem Vomiting (2144)
Event Date 06/28/2018
Event Type  Injury  
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 reported a fresenius 2008k2 machine with a high temperature during treatment. The patient began to vomit and was unable to complete treatment. The patient was removed from the machine after 12 minutes of treatment. There was no blood loss reported, and the patient was hospitalized for observation. The biomedical technician advised the machine passed the self-test repeatedly after the patient was removed, but they were not able to calibrate the temperature until the ntc2 was replaced, which resolved the temperature issues. Additional patient and treatment information was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008K2 OLC ONLY WITH HEPARIN PUMP
Type of DeviceDIALYZER, 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
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7677032
MDR Text Key113634127
Report Number2937457-2018-01924
Device Sequence Number1
Product Code KDI
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190628
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-