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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190766
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2018
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) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine had heat damage on the actuator board. The burned board was noticed during on-site machine repair done by a fresenius regional equipment specialist (res). A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. Upon follow up, the clinical manager confirmed that the biomed replaced the actuator board, function board, and cables, which resolved the issue. The unit was returned to service at the user facility without issue and without reoccurrence of the event. The actuator board was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.
 
Event Description
Plant investigation: the actual devices (functional board and actuator test board) were returned to the manufacturer for physical evaluation. There were no cables returned for failure analysis investigation. The functional board was received with soot on the board, which came from the damaged actuator test board, but there are no signs of physical damage on the components of the functional board. The test machine powered on without alarms or failures with the returned functional board installed. The test machine functioned properly during dialysis, and a self-test was performed and passed. The functional board was determined to be fully operational, despite the char marks on the board. The actuator test board was received with heat damage on ic22, which left soot to nearby components. Ic19 also was damaged, with pin 12 (vmm) broken. There are no other signs of physical damage to the nearby components. A visual inspection of the back of the returned actuator test board showed heat damage. The test machine powered on with the returned actuator test board installed but the display was blank, and an audible alarm sounded continuously. Ic22 and ic19 were replaced and the actuator test board was re-tested. The display went blank and smoke emanated from the actuator test board during power up. The test machine was immediately powered off and the actuator test board was removed for troubleshooting. Further investigation found pin 4 (+24vb) and pin 12 (+24vb) were shorted to all the ground pins on ic22. All of the ic¿s on the stepper motor circuit for the bicarbonate pump (ic19 and ic20), heparin pump (ic21), and concentrate pump (ic23 and ic24) were shorted from +24vb to ground. The returned actuator test board could not be repaired. A review of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key8170131
MDR Text Key130524897
Report Number2937457-2018-03682
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2018
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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