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 Hemolysis (1886)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The cartridge bloodline was discarded and not available for analysis.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This is a report of a patient who was admitted to emergency room due to hemolysis following hemodialysis therapy using a phoenix machine, gambro cartridge bloodline, and a non-baxter dialyzer.During a scheduled 3.5 hour treatment, the patient¿s av fistula needle reportedly infiltrated so the treatment was discontinued.After treatment, the patient observed blood in their urine; however, the patient did not inform the medical staff.The patient was discharged home and again observed blood in their urine.The patient went to the emergency room and was transferred to a hospital where lab data for the patient confirmed the presence of hemolysis.The outcome of the patient was not reported.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; however, eight (8) retained samples were evaluated.Visual inspection of the retained samples 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
• 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: 6949403
• MDR Text Key: 89362367
• Report Number: 8030638-2017-00068
• 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,Followup
• Report Date: 10/13/2017,11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2020
• Device Catalogue Number: 101025
• Device Lot Number: 1000171012
• 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: 10/13/2017
• Distributor Facility Aware Date: 09/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2017
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2017
• 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 Outcome(s): Hospitalization