Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP; HEMODIALYSIS SYSTEM FOR HOME USE
  • 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 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP; HEMODIALYSIS SYSTEM FOR HOME USE Back to Search Results
Model Number 190395
Device Problems Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
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 biomedical technician (biomed) reported to fresenius technical services that a 2008k@home hemodialysis (hd) machine had a saline bag backfill while recirculating during set-up for use.The machine provided an audible alarm along with a ¿10 fill pgm in 1 hr¿ error message.A patient was not connected to the machine at the time of the incident.The biomed reported that the machine does not have the air separator adapter board installed.The fresenius technical support representative advised the biomed to install the air separator board and provided part information.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
 
Event Description
A biomedical technician (biomed) reported to fresenius technical services that a 2008k@home hemodialysis (hd) machine had a saline bag backfill while recirculating during set-up for use.The machine provided an audible alarm along with a ¿10 fill pgm in 1 hr¿ error message.A patient was not connected to the machine at the time of the incident.The biomed reported that the machine does not have the air separator adapter board installed.The fresenius technical support representative advised the biomed to install the air separator board and provided part information.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 did not determine a causal relationship between the objective evidence and the alleged event, therefore the reported issue is not confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP
Type of Device
HEMODIALYSIS SYSTEM FOR HOME USE
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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15076016
MDR Text Key304716833
Report Number0002937457-2022-01215
Device Sequence Number1
Product Code ONW
UDI-Device Identifier00840861100958
UDI-Public00840861100958
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070049
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 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number190395
Device Catalogue Number190395
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-