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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 Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A fresenius (b)(4) technician reported that a fresenius 2008k2 hemodialysis (hd) machine would not turn on and had a melted component.A patient was connected to the machine at the time of the incident.The patient was able to complete treatment on a different machine with no blood loos experienced.There were no reported adverse events or medical intervention required.Upon follow up the fresenius (b)(4) technician stated that they found no problems with the machine and confirmed the clinic was using the machine when they arrived.Additional information was requested however to date has not been provided.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.The fresenius mexico technician stated they found no problems with the machine and confirmed that upon arrival at the clinic, they found the machine in use.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 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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Brand Name
2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key8771274
MDR Text Key150415049
Report Number2937457-2019-02084
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number190618
Was Device Available for Evaluation? No
Device Age MO
Date Manufacturer Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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