• 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 2008T HEMODIALYSIS SYSTEM W/BIBAG 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 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Loss of consciousness (2418); Blood Loss (2597)
Event Date 11/24/2017
Event Type  Death  
Manufacturer Narrative
Medwatch from facility (b)(4) the actual device was not returned to the manufacturer for physical evaluation. However, an investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification. The blood loss and probable cause of hypotension and unresponsiveness was a direct result of the patient's dialysis arterial and venous access needles becoming dislodged from the patient access site. Reportedly this occurred as a result of the failure of the tape to secure the needles to the patients¿ access site. The tape (3m micropore plus paper tape) nor the arterial or venous needles are manufactured by fresenius medical care. There is no documentation or allegation that the 2008t machine or the any other fresenius product malfunction or did not perform as expected.
 
Event Description
A facility administrator reported via medwatch that a hemodialysis patient was 3 3/4 hours in to a scheduled 4 hour hemodialysis treatment when the machine was alarming and patient was found vomiting and unconscious, with blood pressure 57/37; pulse 65. When staff attempted to administer normal saline it was found that both arterial and venous needles were dislodged. Estimated blood loss on floor was 200ml. Patient was re-cannulated with a new fistula needle and a total of 400ml normal saline was administered; oxygen was applied and emergency medical service was called, patient was transported to hospital with the needle site still bleeding with an estimated loss of 250-500 ml blood. The patient was alert at the clinic but by the time she was at the hospital unresponsive, apneic, and pulseless. Patient was treated with advanced life support. The patient had a return of spontaneous circulation twice, but it was not sustained. The patient was defibrillated once for ventricular fibrillation, the patient went into a pulseless electrical arrhythmia (pea) and eventually asystole. The patient was pronounced deceased due to cardiac arrest.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
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 Key7153502
MDR Text Key96001261
Report Number2937457-2017-01457
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190766
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 Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2016
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: 12/28/2017 Patient Sequence Number: 1
-
-