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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 Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/08/2017
Event Type  malfunction  
Manufacturer Narrative
No parts have been returned to the manufacturer for physical evaluation. There have been no adverse events associated with the reported issue. The report is being investigated by the manufacturer via a capa. The plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
 
Event Description
A biomedical engineer at the user facility reported that a 2008k2 hemodialysis (hd) machine had high transmembrane pressure (tmp) of 500mmhg with back pressure to the saline bag while the unit was being set-up for use. A patient was not connected to the machine at the time of the incident. Reportedly, a staff member observed the solution backfill into the saline bag and the bag ¿puffed up. ¿ the biomed confirmed that the unit had received the cbe hardware and software upgrades before the end of 2016. Following the event, the unit was pulled from service for evaluation. The unit remains out of service while the biomed attempts to troubleshoot the issue. No further information has been made available.
 
Manufacturer Narrative
Correction - removed notification remedial action selection and notification # z-0629-2014. The cbe upgrade was performed on this unit. Therefore, this 2008k2 hemodialysis (hd) machine no longer falls within the scope of this recall. 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 unit was pulled from service for evaluation by the biomedical engineer (biomed) following the event. However, no further details were able to be obtained regarding the status of the machine. 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. 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 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 Key6383501
MDR Text Key69274119
Report Number2937457-2017-00146
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 Biomedical Engineer
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008K2
Device Catalogue Number190610
Other Device ID Number00840861100859
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0629-2014

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
Treatment
SALINE (UNKNOWN)
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