MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS OPTIFLUX F180 NRE DIALYZER

Model Number F180NRE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiopulmonary Arrest (1765); Anaphylactoid (2218)

Event Date 10/23/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, pt presented to facility for first outpatient treatment.Pre-tx vital signs stable.Dialysis initiated 6:32 am.Blood pressure 122/74 and pulse 72.At 6:35 am pt complained of feeling dizzy and then became unresponsive.Pt was without pulse or respirations.Cpr initiated and continued until ems arrived at 6:45 am.Ems took over pt care.Pt transported to the hosp.Pt currently in the hosp, still under eval.

• Brand Name: FRESENIUS OPTIFLUX F180 NRE DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; waltham MA
• MDR Report Key: 4487304
• MDR Text Key: 15246929
• Report Number: 4487304
• Device Sequence Number: 1
• Product Code: JQQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F180NRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 76 YR
• Patient Weight: 98