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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING FRESENIUS 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event. However, no malfunction of the 2008k hemodialysis (hd) machine was alleged, observed, or identified by the user facility during the patient's final hd treatment. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the 2008k hemodialysis (hd) machine in question was not known, therefore, the serial number was not able to be provided. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure. " p/n 500658; a device is not released if it does not meet requirements or is nonconforming. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A registered nurse at a user facility reported to post market surveillance that a patient experienced an infection while undergoing hemodialysis (hd) therapy at a hospital. Additional information has been requested, but has not been made available. There was no allegation that a machine, a dialyzer or bloodline malfunction occurred. No parts were available to be returned to the manufacturer for evaluation.
 
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Brand NameFRESENIUS 2008K 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 Key6773185
MDR Text Key250379090
Report Number2937457-2017-00696
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 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/12/2017
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: 08/08/2017 Patient Sequence Number: 1
Treatment
UNKNOWN BLOODLINES; UNKNOWN DIALYZER
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