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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008K2; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770)
Event Date 09/22/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.This event is one of two for the same patient on two separate treatments on (b)(6) 2017.A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient was dialyzing and coded during treatment on (b)(6) 2017.It was unknown if the patient was able to complete hemodialysis treatment.No reported problems were reported with the machine during treatment, and the staff stated that they did not think there was a problem with the machine.Per biomed tech no information about the patient of the incident was available other than the patient showed stroke like symptoms and coded.It was unknown if the patient was sent to the hospital.The staff stated that after the incident the patient seemed okay.When checking the machine before returning to service it gave constant air detector alarm messages.They did not give audible alarms because the dialysate lines were on the shunt.Additional information was requested and was not received to date.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient was dialyzing and coded during treatment on (b)(6) 2017.It was unknown if the patient was able to complete hemodialysis treatment.No reported problems were reported with the machine during treatment, and the staff stated that they did not think there was a problem with the machine.Per biomed tech no information about the patient of the incident was available other than the patient showed stroke like symptoms and coded.It was unknown if the patient was sent to the hospital.The staff stated that after the incident the patient seemed okay.When checking the machine before returning to service it gave constant air detector alarm messages.They did not give audible alarms because the dialysate lines were on the shunt.Additional information was requested and was not received to date.
 
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Brand Name
2008K2
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 Key6965671
MDR Text Key89854151
Report Number2937457-2017-01059
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100859
UDI-Public00840861100859
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,health
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number190610
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 09/22/2017
Initial Date FDA Received10/20/2017
Supplement Dates Manufacturer Received04/05/2018
Supplement Dates FDA Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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