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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Edema (1820)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative
Based on the available information, there is no allegation or documentation that indicates the 2008 k machine caused or contributed to the patient¿s pulmonary edema event. The alleged event was not confirmed by the manufacturing plant. The device was not returned to the plant for investigation. A device history review could not be performed since the lot number is unknown.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Patient (who is currently receiving peritoneal dialysis treatments) medical records received on an unrelated customer experience indicated that the patient was diagnosed and treated for a pulmonary edema on an unknown date. Follow-up with the patient's nurse indicated that the alleged event occurred sometime in 2016. The patient was receiving dialysis treatment at an in-center dialysis clinic at the time. Additional information was solicited.
 
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Brand Name2008K MACHINE
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 Key7142390
MDR Text Key269362812
Report Number2937457-2017-01401
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2008K
Device Catalogue NumberUNKNOWN- 2008K MACHINE
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 Received01/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/22/2017 Patient Sequence Number: 1
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