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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS OPTIFLUX 160 NRE
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FRESENIUS MEDICAL CARE FRESENIUS OPTIFLUX 160 NRE Back to Search Results
Catalog Number 0500316E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Respiratory Distress (2045); Diaphoresis (2452); Diaphoresis (2452)
Event Date 05/05/2019
Event Type  Death  
Event Description
Pt was on dialysis for 13 mins for incenter back up treatment.Pt started coughing, then became sob, and diachoretic.Md called to chairside.No breath sounds heard; 911 called and pt taken to the hospital.Pt was taken off life support and expired on (b)(6) 2019 in hospital.
 
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Brand Name
FRESENIUS OPTIFLUX 160 NRE
Type of Device
OPTIFLUX 160 NRE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
waltham MA 02451
MDR Report Key8817862
MDR Text Key241261548
Report Number8817862
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 User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
2 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Catalogue Number0500316E
Device Lot Number19AU06007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/28/2019
Distributor Facility Aware Date05/15/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/23/2019
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
Patient Outcome(s) Death; Death; Hospitalization; Hospitalization; Life Threatening; Life Threatening;
Patient Age70 YR
Patient Weight92
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