MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA PHOENIX CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Should addition relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 30 minutes after starting treatment with a phoenix cartridge set, the patient experienced an elevated transmembrane pressure (tmp) of 325.It was reported the blood was not going through the dialyzer (no further details).Treatment was discontinued and the blood contained in the arterial blood line was returned to the patient.Treatment was restarted and completed with a different dialysis machine set up.No additional intervention was performed.The patient returned home with a blood pressure (bp) of 181/99 mmhg.Bp prior to treatment was 119/79 and during was 147/93.The following day, the patient presented to the emergency room with signs and symptoms of hemolysis.It was not reported if the patient was hospitalized for the event.Treatment and interventions were not reported.At the time of this report, the patient was recovered.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 8375453
• MDR Text Key: 137309997
• Report Number: 8030638-2019-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2019,05/03/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Distributor Facility Aware Date: 02/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE; REVACLEAR DIALYZER; PHOENIX MACHINE; REVACLEAR DIALYZER
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 99