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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 Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A patient care technician (pct) for a user facility reported that the fresenius 2008t hemodialysis (hd) machine was giving an ¿a24 optical tachometer not in range¿ alarm on the blood pump during patient treatment. The patient¿s blood could not be returned as the alarm caused blood pump failure and the blood started to clot within the extracorporeal circuit. Follow-up information with the clinic manager revealed that the alarm occurred near the end of the treatment. The staff attempted to return the patient¿s blood and administered 5000 units of heparin, however, not all of the blood was able to be returned due to clotting within the bloodline. The patient¿s estimated blood loss was reportedly less than 100ml. There was no patient injury or adverse reaction reported. Following the event, the patient was disconnected from the machine. The patient did not complete treatment as the incident reportedly occurred near the end of the scheduled treatment time. There was no reported defect or malfunction with the bloodlines that were used for the patient treatment. Following the event, the machine was removed from service for evaluation by the user facility¿s biomedical technician (biomed). The biomed verified machine operations and was unable to duplicate the issue. The machine was placed back into service after all tests passed by the biomed. No parts are reported to be available to be returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The user facility biomedical technician (biomed) was unable to duplicate any blood pump failure and verified machine operations. The unit was returned to service at the user facility. 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 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. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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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
MDR Report Key7279708
MDR Text Key100525277
Report Number2937457-2018-00502
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2018
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
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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