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

Catalog Number 101025

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch #: mw5086169.Should addition relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the arterial and venous clamp/port of hd cartridge lines were defective and reversed during patient treatment.The arterial clamps and port were on the venous line.The venous port was in line with arterial port and this resulted in a reverse treatment procedure where instead of rinsing back, to the patient, blood was being pulled from the patient.There was no report of patient injury or medical intervention associated with this event.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.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned and the lot number is not confirmed; therefore, a device analysis could not be completed.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: 8679655
• MDR Text Key: 208782959
• Report Number: 8030638-2019-00007
• 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: 06/07/2019,10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: 1000211722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Distributor Facility Aware Date: 05/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1