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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K2
Device Problem Pumping Stopped (1503)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2017
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. The 2008k2 hd machine was removed from service for evaluation following the event. An issue was observed with the blood pump rotor roller pins. The blood pump module was replaced by the biomed to resolve the issue. Following the part replacement, the unit was restored to full functionality. Functional testing performed by the biomed confirmed the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported. 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 medwatch report will be submitted at the completion of this activity.
 
Event Description
The charge nurse at the user facility originally reported that the blood pump was not pushing blood through the extracorporeal circuit during the patient's hemodialysis (hd) treatment. The blood pump module was inspected and the rotor roller pins were found to be "backing out with damage to housing. " however, follow-up information was provided by an administrator at the user facility, who revealed that the event was not caused by faulty parts. The patient's venous needle dislodged due to the patient moving. The patient was re-cannulated, but when the staff attempted to re-start the hd treatment, the 2008k2 hd machine generated an arterial pressure alarm that was not able to be cleared. The blood clotted in the lines so the extracorporeal circuit was discarded. The patient's estimated blood loss (ebl) was noted as being approximately 500 milliliters (ml). The patient was re-setup on a different machine, and then the treatment was continued and successfully completed. No patient adverse effects were experienced and no medical intervention was required as a result of this event. Additionally, a non-fresenius manufactured dialyzer and bloodline were in use during this hd treatment. The biomedical technician at the user facility provided follow-up information related to this event. According to the biomed, the 2008k2 hd machine was removed from service for evaluation following the event. An issue was observed with the blood pump rotor roller pins. The blood pump module was replaced by the biomed to resolve the issue. Following the part replacement, the unit was restored to full functionality. Functional testing performed by the biomed confirmed the system was operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported. No parts were available to be returned to the manufacturer for evaluation.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key6691074
MDR Text Key162947545
Report Number2937457-2017-00544
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008K2
Device Catalogue Number190610
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 Received07/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2009
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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