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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190305
Device Problems Mechanical Problem (1384); Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius field service technician (fst). 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-conformances, 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.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill in recirculation mode, during set-up for use. There was no patient involvement associated with the event. The biomed did not report that there were any machine alarms. Multiple attempts were made to contact the biomed and obtain additional information. Thus far, those attempts have proven unsuccessful. It is unknown if any parts were replaced and/or if they are available to be returned for physical evaluation.
 
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Brand Name2008K OLC ONLY WITH HEPARIN PUMP
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14000250
MDR Text Key289530092
Report Number2937457-2022-00571
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2002
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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