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

Catalog Number ASKU

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a ¿venous disconnection event¿ occurred during treatment with a phoenix machine, hd cartridge line and a central catheter.The patient experienced a 500 ml blood loss.There was no report of patient injury or medical intervention associated with this event.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.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; deerfield IL
• MDR Report Key: 9375784
• MDR Text Key: 195413437
• Report Number: 8030638-2019-00018
• 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,Followup
• Report Date: 11/25/2019,12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2019
• Distributor Facility Aware Date: 11/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/03/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/08/2019; 12/17/2020
• Supplement Dates FDA Received: 12/17/2019; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE