• 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 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 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008T MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 04/06/2018
Event Type  Death  
Manufacturer Narrative
A temporal association with the adverse events of the patient being found unresponsive leading to the expiration of the patient and the fresenius 2008t machine, and micera, and venofer administration exist. However, there is no documentation or allegations of any malfunction with the 2008t machine. It is unknown if the patient had previously experienced any reaction with the administration of venofer and micera or if this event is related to the administration during this hd treatment. According to the micera label found on the fda website ¿esas are known to increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access and tumor progression or recurrence¿. It is unknown if the patient¿s many comorbidities contributed to the event. The causality of the event cannot be determined based on the limited information received. A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
On 13/apr/2018 a copy of a voluntary medwatch (0527520000-2018-0001) was received from a hemodialysis (hd) clinic concerning this male patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) to make notification that the patient expired during hd treatment on (b)(6) 2018. The medwatch indicated that the patient attended a scheduled hd treatment on (b)(6) 2018. The patient¿s pre-treatment vital signs were assessed blood pressure (bp) 109/70, pulse 67, respirations 18, temperature 97. 7° and a pre-weight of (b)(6) kg. Dialysis was initiated at approximately 1640 hours (total scheduled time for treatment unknown) with a bp 169/97 and pulse 65. At approximately 1703 hours the patient was administered venofer 100 mg intravenous push (ivp) and at 1704 was administered micera 200 mcg ivp. It was noted that the patient¿s first dose of micera was administered during treatment on (b)(6) 2018 with 75 mcg. It is unknown when the patient was first administered venofer. The patient became unresponsive at approximately 1712 hours. It is unknown if the patient was found unresponsive during a routine check. At this time hd treatment was terminated and 911 was called. Cpr was initiated (no details provided). The patient was transported to the hospital (unknown if patient was still unresponsive at time of transport) and subsequently expired. Additional resuscitative efforts are unknown. Additional information was solicited.
 
Manufacturer Narrative
The alleged event is not confirmed. The device was not returned to the manufacturing plant for investigation. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. A device history review was not performed since the serial number of the alleged device is unknown.
 
Event Description
". ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T 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 Key7482967
MDR Text Key107219257
Report Number2937457-2018-01219
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/12/2018,07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number2008T MACHINE
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2018
Device AgeMO
Event Location No Information
Date Manufacturer Received07/18/2018
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: 05/03/2018 Patient Sequence Number: 1
Treatment
MICERA (23/MAR/2018 75MCG FIRST DOSE); VENOFER; VIFOR
-
-