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

Catalog Number 101025

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

Patient Problem Hemolytic Anemia (2279)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.

Event Description

It was reported that a patient experienced hemolytic anemia after treatment using a gambro cartridge set.The reporter stated that within 30 minutes of starting treatment with a gambro cartridge set, the nurse heard a ¿sucking noise¿ coming from a phoenix machine.The nurse flushed the extracorporeal circuit with saline with no indication of clotting noted.The venous pressure was reported to be 40 mm/hg with a blood pump speed of 430 ml/min.The reporter ¿tried using a little o-ring lubricant¿ with no change in pressures.Treatment was discontinued.The blood was not returned to the patient and the circuit was found to be clotted.Treatment was resumed on a different machine without further reported issues.Later the same day, the patient presented to the hospital and was diagnosed with hemolytic anemia.The cause of the event was unknown.At the time of this report, the patient outcome was reported as ¿patient¿s current status is good¿.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation, however, eight retained samples were evaluated.Visual inspection and leak tests were performed and did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 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: 7739918
• MDR Text Key: 115710121
• Report Number: 8030638-2018-00012
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/01/2018,08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2018
• Distributor Facility Aware Date: 07/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2018
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE; PHOENIX MACHINE
• Patient Outcome(s): Other