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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 Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) after the customer recalibrated the air detector and performed a rotor occlusion pressure test on the machine, which failed. The res attempted to verify the rotor occlusion test on the machine, but the blood pump rotor failed, achieving no more than 15-17 psi. The res advised the customer to replace the rotor or arterial blood pump module, stating that the minimum 25 psi could be achieved by ensuring the water was warmed above 37°c. The res did not make any repairs and completed the machine functional checks. 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 identified 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 able to be confirmed. The res verified that the machine¿s blood pump rotor was not achieving the minimum 25 psi. The res advised the customer to replace the rotor or arterial blood pump module, but the res did not make any repairs and completed the machine functional checks.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) for a user facility reported that there was visible air in the patient¿s blood pump segment of the bloodlines approximately 30 to 60 minutes after the initiation of a patient¿s hemodialysis (hd) treatment while using a fresenius 2008t hd machine. The machine did not alarm as the air was noticed prior to the air detector module and occlusion clamp. The priming technique was reported to be performed correctly. There was no patient injury or adverse reaction reported and no medical intervention was required. It was not stated that the patient¿s blood was returned; nor was it stated that there was no blood loss. However, it was stated that after the nurse evaluated the patient following the event, the patient was able to complete treatment without further issue. Following the event, the machine was removed from service for evaluation. The atom recalibrated the air detector and performed a rotor occlusion pressure test on the machine. The test results were below the expected range. A fresenius regional equipment specialist (res) performed on-site service. The res attempted to verify the rotor occlusion test, but the blood pump rotor failed, achieving no more than 15-17 psi. The res advised the atmo to replace the rotor or arterial blood pump module, stating that the minimum 25 psi could be achieved by ensuring the water was warmed above 37°c. The res did not make any repairs and completed the machine functional checks. No defect or damage was reported with the dialyzer, bloodlines, or packaging. There were no external leaks noted. No machine parts were stated to be available to be returned to the manufacturer for evaluation.
 
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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 Key7128820
MDR Text Key258914300
Report Number2937457-2017-01356
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
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
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? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated by Manufacturer? Yes
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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