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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190618
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Date 04/13/2019
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a fresenius 2008k2 hemodialysis machine had fuses that were visibly melted. The issue was found when the machine was being serviced for not powering on prior to use. It was confirmed that a patient was not connected to the machine when the issue occurred. A fresenius (b)(4) technician reportedly replaced the power source fuses to resolve the issue and return the machine to service. Upon additional follow up, it was confirmed that the fuses were melted. Additional information was requested, but was not provided. If additional information is received, a supplemental report will be submitted.
 
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Brand Name2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
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
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8583685
MDR Text Key144719805
Report Number2937457-2019-01335
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190618
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2013
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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