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

Catalog Number 101025

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was not received for evaluation; therefore, a device analysis could not be performed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient undergoing dialysis treatment with a cartridge bloodline experienced an air in chamber alarm.Approximately two hours into treatment, the machine triggered an air in chamber alarm.The nurse tried and failed to remove the air, and upon further visual inspection, noticed the presence of a crack in the chamber with internal blood leakage.A blood loss of more than 150 ml was reported.Treatment was interrupted without returning the blood to 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 was no deviation 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 did not identify any abnormalities that could have contributed to the reported condition.Under water leak testing was performed, and no leaks were observed.Simulated use testing was performed with three retention samples, and it was determined that the sets could be loaded correctly, complete priming and treatment without leaks from the cartridge.No alarms were observed.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
• Manufacturer (Section G): BAXTER HEALTHCARE - TIJUANA BAJA; blvd pacifico 10014; parque industrial pacifico; tijuana baja california CP 22 643; MX CP 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7549796
• MDR Text Key: 109509309
• Report Number: 8030638-2018-00006
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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 Expiration Date: 10/15/2020
• Device Catalogue Number: 101025
• Device Lot Number: 1000180149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/04/2018
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR