MAUDE Adverse Event Report: FRESENIUS USA MANUFACTURING, INC. FRESENIUS OPTIFLUX 180NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 180NRE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907); Respiratory Arrest (4461)

Event Date 06/12/2023

Event Type  Injury  

Event Description

Patient arrived for scheduled dialysis treatment.Pre vs: bp 162/70 pulse 87 resp 18 temp 97.2.Dialysis started at 11:06, bp 143/63, pulse 78.Approx.25 minutes later, patient unresponsive, no pulse, no respirations noted.Cpr (cardiopulmonary resuscitation) initiated and 911 called.After approx.2 rounds of cpr, rosc (return of spontaneous circulation) achieved, patient placed on 10l o2 via mask, ems (emergency medical services) arrived and assumed care.Patient transported to hospital and is presently in rehab center.Patient treated on an optiflux dialyzer.Optiflux dialyzers added to allergy list.

• Brand Name: FRESENIUS OPTIFLUX 180NRE DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA MANUFACTURING, INC.
• MDR Report Key: 17269646
• MDR Text Key: 318609307
• Report Number: MW5119150
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 180NRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2023
• Patient Sequence Number: 1
• Treatment: COMBISET BLOODLINES.; FRESENIUS 2008T MACHINE.; GRANUFLO 2.0K 2.5CA 1.0MG 100 DEXTROSE.; NATURALYTE BICARBONATE.; NORMAL SALINE.
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American