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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
Model Number 2008T
Device Problem Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
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 was provided by the biomedical technician which revealed that the system was removed from service for evaluation following the event. The biomed revealed that the only finding was a small leak in the heat exchanger. The biomed is waiting to receive clearance to perform the system repairs. The current repair status is not known. 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.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A clinician at the user facility reported that a 2008t hemodialysis (hd) machine generated a dial valve failure alarm while a patient underwent a hemodialysis (hd) treatment. The blood pump stopped, and the alarm was not able to be cleared, silenced, or reset. The treatment was terminated two (2) hours and twelve (12) minutes after the hd therapy was initiated. The blood within the arterial line of the extracorporeal circuit was rinsed back, and an attempt to return the blood within the venous line was made using the manual hand crank. However, the staff was unsuccessful in returning the blood in the venous line which was thought to be clotted due to its very dark appearance. The patient¿s estimated blood loss (ebl) was noted as being about 200 milliliters (ml). No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient¿s condition was stable and vitals were fine. The patient¿s post-treatment condition was noted as being ¿fine. ¿ following the event, the system was removed from service for evaluation. Functional testing performed by the biomed found the system was operating properly. The biomed revealed that the only finding was a small leak in the heat exchanger. The biomed is waiting to receive clearance to perform the system repairs. The current repair status is not known.
 
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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 Key6593795
MDR Text Key162944740
Report Number2937457-2017-00403
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 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Device Catalogue Number190713
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 Manufactured07/28/2011
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: 05/26/2017 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINE; FRESENIUS DIALYZER; FRESENIUS SALINE
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