• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING 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 Problems Anemia (1706); Hypoglycemia (1912); Hypoxia (1918); Electrolyte Imbalance (2196); Confusion/ Disorientation (2553); Hypervolemia (2664)
Event Date 02/05/2017
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: there is no documentation in the file or medical record received to indicate a potential causal relationship between hd treatment and the patient experiencing altered mental status and leg weakness with subsequent hospital admission for hypervolemia, hypoxia, electrolyte imbalance hypoglycemia and metabolic encephalopathy. Additionally there are no reported allegations against any fresenius products and the adverse events. However, there is a strong possible association between the patient¿s complex medical history (including multiple cardiac issues), as well as hypoglycemia, hypoxia, hyponatremia and metabolic encephalopathy which all have symptomatology of altered mental status. 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
Review of the medical records indicated that a hemodialysis (hd) patient was hospitalized due to altered mental status. The patient had only been undergoing hd therapy for the past one (1) month. The following details were provided for the adverse event. The patient have been receiving hd therapy on a 2008k hd machine. It was reported that the patient experienced altered mental status on the morning of (b)(6) 2017. Follow-up confirmed the patient was at the nursing home and not undergoing hd treatment at the time of the incident. The patient was hospitalized and has recovered. No malfunctions of the 2008k hd machine were observed or identified, prior to, during, or following any hd treatments. There was no allegation that any dialyzer malfunction occurred. The machine is not available to be returned to the manufacturer for evaluation. The dialyzer products were not available to be returned to the manufacturer for evaluation as they were discarded by the user facility.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6749569
MDR Text Key245893796
Report Number2937457-2017-00643
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2017
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 Received07/28/2017
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: 07/27/2017 Patient Sequence Number: 1
Treatment
FRESENIUS F160NR DIALYZER
-
-