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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 Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: 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). The res replaced the level detector module in response to the customer¿s report of tmp alarms occurring during patient treatment. 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-conformance 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 able to confirm the failure mode. The res had to replace the level detector module. Therefore, the complaint has been deemed confirmed.
 
Event Description
A fresenius regional equipment specialist (res) performed on-site service on (b)(6) 2017. After speaking with the customer, the res replaced the level detector module. All functional checks passed. It was stated by the res that the machine had alarmed during a patient treatment, but the patient was not removed from the machine and there was no patient injury. No parts are reported to be available to be returned to the manufacturer for evaluation.
 
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 the fresenius 2008t hemodialysis (hd) machine was giving arterial pressure, venous pressure, and transmembrane pressure (tmp) alarms during patient treatment. The arterial drip chamber would run low or out of blood and the venous chamber would overfill and wet the venous transducer. The patient¿s blood clotted in the venous chamber, resulting in blood loss. There was no patient injury or adverse reaction reported. The patient¿s blood was returned and the staff changed the venous line and the patient completed treatment. The dialyzer is primed at 150ml/min. The machine is set-up with bloodlines and the venous chamber is primed. The arterial and venous transducer lines are clamped and hung from the pressure ports with the transducers attached. The machine self-test runs and when the patient arrives, the arterial and venous transducer lines are attached to the pressure ports and the hansen lines are connected to the dialyzer where the priming is completed. The dialyzer is inverted during the priming of the circuit. Following the event, the machine was removed from service for evaluation. The atom has troubleshooted the machine but has not identified the source of the issue. The machine continues to have the issue. The machine is currently in use at the user facility. No parts are reported to be available to be returned to the manufacturer for evaluation. No further information has been made available at this time.
 
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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 Key7042495
MDR Text Key252422863
Report Number2937457-2017-01199
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2017
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 Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2017
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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