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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

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K2
Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2017
Event Type  malfunction  
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 saline bag backfill occurred following the initiation of a patient's hemodialysis (hd) treatment on a 2008k2 hd machine. Reportedly, the staff had replaced the saline bag at the start of treatment, and subsequently noticed that the saline bag backfilled. The treatment was stopped, the saline bag was replaced, and then the blood within the extracorporeal circuit was returned to the patient; no blood was lost. The patient was moved to a different machine, and then the treatment was continued and successfully completed with no further issues. No patient adverse effects were experienced and no medical intervention was required as a result of this event. Follow-up was provided which revealed that the cbe upgrade was previously performed on this unit. Following the event, the system was removed from service for evaluation. The biomed replaced the air separator, valve 43, and a sensor to resolve the issue. 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 as all replaced components were discarded by the user facility.
 
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. The biomedical engineer indicated that the air separator, valve 43, and a sensor were replaced to resolve the issue. 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. 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. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key6509108
MDR Text Key73347087
Report Number2937457-2017-00275
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008K2
Device Catalogue Number190610
Other Device ID Number00840861100859
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 Received05/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2010
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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