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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 Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. Follow-up with the biomedical technician indicated the machine was removed from service for evaluation following the event. The biomedical technician replaced valve 24 and repaired the shunt door switch to resolve the issue. Following the parts replacement and repair, the system was restored to full functionality. The unit has been returned to service at the user facility without a recurrence of the event as reported. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were non-conformance's 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. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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 at the user facility reported that a 2008t hemodialysis (hd) machine generated a dial valve fail 2 alarm while a patient was undergoing hd treatment. The blood within the extracorporeal circuit was partially returned, the patient was resetup on an alternate system, and then the hd treatment was continued and successfully completed. The patient's estimated blood loss (ebl) was noted as being approximately 100 milliliters (ml). No patient adverse events were experienced and no medical intervention was required as a result of this event. The patient vitals were noted as being fine. Follow-up revealed that the system was removed from service for evaluation. The biomed replaced valve 24 and modified the shunt door switch which resolved the issue. Following the repair activities, the system was restored to full functionality. Functional testing performed by the biomed confirmed the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported. No parts were available to be returned to the manufacturer for evaluation.
 
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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 Key6556778
MDR Text Key160448079
Report Number2937457-2017-00346
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,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190713
Other Device ID Number00840861100897
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 Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/10/2017 Patient Sequence Number: 1
Treatment
FRESENIUS DIALYZER; FRESENIUS SALINE
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