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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
Catalog Number 190713
Device Problem Partial Blockage (1065)
Patient Problem Blood Loss (2597)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Occupation: biomedical engineer. Plant investigation: 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 biomedical engineer (biomed tech) reported during a hemodialysis treatment the hd machine prompted with a "remove usb 2 device" alarm. Hen they were removing the patient the patient there was reported blood loss. Per biomed tech there was no harm to the patient, and the patient was moved to another machine. Additional information provided from the clinic manager revealed the dialysis machine generated a blood leak alarm 3 hours and 43 minutes after the hd therapy was initiated. The clinic manager stated the cause of the blood loss was due to a clotted dialyzer. No damage to the dialyzer or packaging was noted. The patient¿s estimated blood loss (ebl) was approximately 150ml. The clinic manager stated no patient adverse effects were experienced and no medical intervention was required as a result of this event. The machine was removed from service and was considered as a spare machine at this time. Additional information was requested.
 
Manufacturer Narrative
Additional information added: describe event or problem.
 
Event Description
A biomedical engineer (biomed tech) reported during a hemodialysis treatment the hd machine prompted with a "remove usb 2 device" alarm. When they were removing the patient the patient there was reported blood loss. Per biomed tech there was no harm to the patient, and the patient was moved to another machine. Additional information provided from the clinic manager revealed the dialysis machine generated a blood leak alarm 3 hours and 43 minutes after the hd therapy was initiated. The clinic manager stated the cause of the blood loss was due to a clotted dialyzer. No damage to the dialyzer or packaging was noted. The patient¿s estimated blood loss (ebl) was approximately 150ml. The clinic manager stated no patient adverse effects were experienced and no medical intervention was required as a result of this event. Per clinic manager there was no injury to the patient and the patient has been able to continue in-center hemodialysis treatments without issue. The hemodialysis machine was also placed back in service without further issue.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported during a hemodialysis treatment the hd machine prompted with a "remove usb 2 device" alarm. Then they were removing the patient the patient there was reported blood loss. Per biomed tech there was no harm to the patient, and the patient was moved to another machine. Additional information provided from the clinic manager revealed the dialysis machine generated a blood leak alarm 3 hours and 43 minutes after the hd therapy was initiated. The clinic manager stated the cause of the blood loss was due to a clotted dialyzer. No damage to the dialyzer or packaging was noted. The patient¿s estimated blood loss (ebl) was approximately 150ml. The clinic manager stated no patient adverse effects were experienced and no medical intervention was required as a result of this event. The machine was removed from service and was considered as a spare machine at this time. Additional information was requested.
 
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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 Key7100255
MDR Text Key248238126
Report Number2937457-2017-01311
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/03/2018
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 Number190713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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