Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS; HEMODIALYSIS MACHINE
  • 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
 

FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS; HEMODIALYSIS MACHINE Back to Search Results
Model Number 2008K
Device Problem High pH (2426)
Patient Problem Cardiac Arrest (1762)
Event Date 05/02/2016
Event Type  Death  
Event Description
At 14:20 pm, almost 3 hours into dialysis treatment, the patient became unresponsive with no pulse.Cpr was initiated and 911 called.Ems arrived and cpr continued for 30 minutes when a pulse was finally achieved.Patient was subsequently transported to the hospital; however, expired in the emergency room.Dialysis machine was pulled for function testing after the event.Ph was noted to be out of range at 8.4 using a phoenix meter.Pre-treatment ph was noted to be 7.5.Calibration of phoenix meter was verified and subsequent tests gave same result of 8.4.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FRESENIUS
Type of Device
HEMODIALYSIS MACHINE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter st.
waltham MA 02451
MDR Report Key5723155
MDR Text Key47341194
Report Number5723155
Device Sequence Number1
Product Code ONW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model Number2008K
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/16/2016
Distributor Facility Aware Date05/02/2016
Device Age9 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/16/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
USED 3X/WEEK EVERY MON, WED, AND FRI.
Patient Outcome(s) Death;
Patient Age87 YR
Patient Weight58
-
-