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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
Catalog Number 190610
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: no parts were returned to the manufacturer for physical evaluation. The 2008k2 hemodialysis (hd) machine was evaluated at the patient¿s home by the fresenius regional equipment specialist (res). The res could not duplicate the reported complaint. The functional checks were performed, and the device functioned as expected without issues. It was reported by the biomedical engineer (biomed) that sometime after the res evaluation of the machine, the biomed replaced the level detector to address the reported venous pressure issue. The patient reportedly continues to use the hd machine with no further problems. 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 not able to be confirmed. The res verified that the machine was operating properly. Therefore, the complaint is not confirmed.
 
Event Description
The biomedical engineer (biomed) reported that the machine was alarming for venous pressure at the beginning of the patient's treatment and then shortly after, the blood backed up into the venous line venous transducer and shot out and the transducer popped off. The estimated blood loss volume is unknown. The patient did not re-set up supplies to complete treatment. Instead, the patient decided to go to the dci north brunswick hemodialysis (hd) clinic to have treatment. There was no medical intervention required as a result of this event. Following the services provided on the machine at the patient¿s home by a fresenius regional equipment specialist (res), the biomed replaced the level detector. The patient continues to use the machine after the level detector was replaced. The biomed stated that the patient is (b)(6) years old.
 
Manufacturer Narrative
During fresenius regional equipment specialist (res) field investigation, the investigator (res) could not duplicate the reported complaint. The functional checks were performed and the device functioned as expected without issues. The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A biomedical engineer (biomed) at a user facility reported that the fresenius 2008k2 hemodialysis (hd) machine had low flow error and venous pressure issues. It was stated that there is excess pressure in the venous chamber 1. 5 hours into treatment. This machine is located at a patient¿s home for hd home use. A fresenius regional equipment specialist (res) performed an on-site service. The res verified hydraulic pressure, arterial pressure, and venous pressure calibrations. The res performed a simulated use with the unit using the patient¿s prescribed parameters and 2 hour simulated treatment. There were no observed issues or machine alarms. The res was unable to duplicate the reported complaint event and confirmed the machine functioned properly. Follow-up information with the biomed revealed that the air detector was replaced as it would not stop the blood pump when required causing the blood lines to break, resulting in patient blood loss. There was no reported patient injury or adverse event. The machine has since been returned to service at the patient¿s home. No parts were stated to be 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 Key7163480
MDR Text Key275465810
Report Number2937457-2018-00046
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received01/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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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