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 Problems Hemolysis (1886); Weakness (2145); Confusion/ Disorientation (2553)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

Lot number ¿ the customer reported two potentially associated lot numbers, 1000176823 and 1000179536.The actual device was not available; however, companion samples were received for evaluation.The customer returned 15 unused samples of lot 1000176823 and 15 unused samples of lot 1000179536.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A dimensional check of the transport tubes and pump segment and a venous filter inspection were performed on all 30 samples with no issues noted.A batch review was conducted for both potentially associated lot numbers and there were no deviations found related to this reported condition during the manufacture of either lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced hemolysis after hemodialysis treatment using a cartridge bloodline set, a baxter dialysis machine, a non-baxter dialyzer, and a non-baxter fistula needle.Treatment started with the following prescribed machine settings: blood flow rate 400ml/min and dialysate flow rate 800ml/min.Treatment was completed without reported issues.Following completion of treatment, the patient went to the bathroom and discovered that their urine was red colored.The patient, who was also febrile, was transferred to the emergency room and admitted to the hospital for two days.The patient, who had complained of feeling ¿whoosy¿ prior to starting treatment, appeared anxious and confused at the emergency room.Blood was reportedly found hemolyzed.The patient was treated with antibiotics and 1500ml saline solution.The patient was discharged after two day feeling well.The antibiotics were discontinued upon discharge from the hospital.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: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7336421
• MDR Text Key: 102309762
• Report Number: 8030638-2018-00003
• 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: Other
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Distributor Facility Aware Date: 02/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2018
• Date Manufacturer Received: 02/12/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 89