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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190371
Device Problems Inadequate Ultra Filtration (1656); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2018
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 user facility biomedical technician (bmt) reported a fresenius 2008k2 hemodialysis (hd) machine had an ultrafiltration rate problem and a slow-running treatment time during setup. A fresenius regional equipment specialist (res) performed on-site repairs to the machine and it has been returned to service. Upon follow up, the bmt confirmed that there was no patient involvement, injury, adverse events, or medical intervention required as a result of the reported event.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation. A fresenius regional equipment specialist (res) performed on-site repairs to the machine. The res stated that the reported issues could not be duplicated and the machine has been returned to service. A serial number search in the complaint handling system found no complaint issues with the same symptom within 90 days of the notified date. The cause of the reported event was not able to be confirmed.
 
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Brand Name2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key8166048
MDR Text Key130476734
Report Number2937457-2018-03666
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267 
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190371
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

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