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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX ADVANCED FRESENIUS POLYSULFONE F180 NR, ETHYLENE OXIDE STERILIZED

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FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX ADVANCED FRESENIUS POLYSULFONE F180 NR, ETHYLENE OXIDE STERILIZED Back to Search Results
Model Number F180 NR
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Reaction (2414)
Event Date 04/13/2017
Event Type  Death  
Event Description
Pt and daughter arrived for 10:40 appointment. Charge nurse reviewed and obtained admission documents. Pt to hemodialysis chair at 11:00 am. Pre-treatment assessment, vss with bp at 135/45, pulse
=
60, resp
=
16, temp
=
97. 5. Hemodialysis treatment started at 11:23 am with bp at 141/58. P
=
60, at 1130, nurse attempted to obtain o2 saturation % on pt related to pt continuing to pull off nasal cannula, pt suddenly lost consciousness, and became completely unresponsive. Pt placed in trendelenburg and rn called for assistance. Cpr initiated, pt's blood returned, 911 called, aed pads applied. Aed analyzed first time with no shock advised, cpr resumed. Ambu bag utilized. At 1140 ems arrived. Cpr still in progress. Aed analyzed second time with no shock advised. Emergency meds given per ems protocol through pt's cvc. Pt intubated by ems personnel, transferred care to ems. Medical center notified facility of pt's death.
 
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Brand NameOPTIFLUX ADVANCED FRESENIUS POLYSULFONE
Type of DeviceF180 NR, ETHYLENE OXIDE STERILIZED
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA
MDR Report Key6576683
MDR Text Key75524384
Report Number6576683
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberF180 NR
Device Catalogue Number0500318N
Device Lot Number16CU04013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/26/2017
Distributor Facility Aware Date04/13/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/26/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/17/2017 Patient Sequence Number: 1
Treatment
COMBISET, 0.9% NORMAL SALINE; FRESENIUS T MACHINE
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