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); Reaction (2414)

Event Date 12/01/2017

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 the 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.The patient was stable prior to treatment start.The prescribed machine settings were: blood flow rate 450 ml/min, dialysate flow rate 800 ml/min.No visible defects were observed in the bloodlines.Four hours into treatment, the baxter dialysis machine generated the "inlet pressure max" alarm.100ml of normal saline was administered to the patient ¿to check for clotting in dialyzer.¿ treatment was discontinued (reason for discontinuation not reported).It was at this time the patient experienced ¿allergic type reaction with red blotches on face and trunk.¿ it was also reported that the patient had ¿blood shot eyes¿ and ¿lower lid conjunctivitis.¿ the physician was notified and prescribed 25mg benadryl to the patient.Since the symptoms did not resolve, the physician encouraged the patient to go to the emergency department where it was determined that the patient's blood was hemolyzed.The actions taken at the emergency department were not reported.The patient was not admitted to the hospital.The patient outcome was not reported 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: 7336145
• MDR Text Key: 102313213
• Report Number: 8030638-2018-00002
• 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 Age: 59 YR
• Patient Weight: 105