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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 Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure. A device is not released if it does not meet requirements or is nonconforming. In addition, the device record review confirmed the labeling, material, and process controls were within specification.
 
Event Description
A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment. No alarm was noted. The air was noted to have passed the occlusion clamp around the needle area. No external leaks were noted. The patient was removed from machine and blood was not returned to patient. The patient's blood loss was 300ml. The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released. The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day. The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment. No alarm was noted. The air was noted to have passed the occlusion clamp around the needle area. No external leaks were noted. The patient was removed from machine and blood was not returned to patient. The patient's blood loss was 300 ml. The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released. The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day. The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.
 
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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 Key7099524
MDR Text Key192680787
Report Number2937457-2017-01309
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 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2016
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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