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

Catalog Number 101025

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately 15-30 minutes during treatment with a cartridge bloodline, the dialysis machine generated several "air in blood" alarms.Eventually the alarms cleared but no air or bubbles could be observed within the extra-corporeal circuit.As a result of the alarms, the patient experienced shortness of breath and chest pain.The patient was placed in minimum ultrafiltration rate and in a trendelenburg position and received saline due to hypotension.Reportedly the symptoms dissipated.No additional information is available.

• 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: your company street; your company town, IL 99999 ; 2242702068
• MDR Report Key: 7814295
• MDR Text Key: 118166876
• Report Number: 8030638-2018-00016
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2018
• Distributor Facility Aware Date: 07/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2018
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: HOSPIRA 0.9% NACI SALINE BAG; PHOENIX / INNOVA MACHINE; REVACLEAR DIALZYERS; REXEED 25S (NON-BAXTER PRODUCT)
• Patient Outcome(s): Other