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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 Alarm Not Visible (1022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
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 clinic manager reported that a dialyzer blood leak occurred immediately into patient¿s hemodialysis (hd) treatment. The blood leak was noted as being an internal blood leak. The leak was visually observed at as bright red tinge on the dialysate at the bottom of the dialyzer. The machine, a fresenius 2008t machine, did not alarm appropriately with a blood leak alarm. The patient¿s estimated blood loss (ebl) was approximately 100 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a new machine and treatment completed successfully with new supplies. The in-house biomedical technician (biomed) stated that the machine was evaluated and passed functional checks.
 
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 unit was pulled from service for evaluation following the event. Functional testing performed by the biomed confirmed that the system was operating properly. The 2008t hemodialysis (hd) machine was returned to service at the user facility without issue. The 2008t hemodialysis (hd) machine was returned to service at the user facility without 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 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. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. Should additional relevant information become available, a supplemental report will be submitted.
 
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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
MDR Report Key7504270
MDR Text Key108146407
Report Number2937457-2018-01308
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/10/2018 Patient Sequence Number: 1
Treatment
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
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