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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem No Audible Alarm (1019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The biomedical technician (biomed) re-soldered the speaker wire to resolve the issue. 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 during the manufacturing process which could be associated with 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.
 
Event Description
Additional information was received from the biomedical technician (biomed). The biomed confirmed that the wire had a faulty solder connection. The biomed re-soldered the wire, which resolved the issue. The machine was returned to service at the user facility without further problems. Additional information was received from the user facility nurse. There was minor patient blood loss. There was no patient injury or adverse reaction and no medical intervention was required. The machine's audible alarm was not noticed at some point during treatment. The nurse stated that she could not identify the specific alarm, but believed it was for blood pump failure. There was minor blood clotting within the extracorporeal blood circuit. The nurse stated that the patient did not require any additional treatments.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine did not give audible alarms during a patient treatment and the patient's blood "clotted off". An unknown amount of blood loss was reported. The biomed did not report any patient injury or adverse reaction. The biomed did not know if the patient was able to complete treatment. The biomed found the yellow wire to the speaker was not well soldered. The wire moved on the connection. The audible alarms were intermittent during power-up. No further information has been made available at this time.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key7053037
MDR Text Key251103822
Report Number2937457-2017-01228
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2014
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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