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 Abdominal Pain (1685); Hemolysis (1886); Nausea (1970)

Event Date 02/08/2018

Event Type  Death  

Manufacturer Narrative

Lot number ¿ the customer reported two potentially associated lot numbers, 1000176823 and 1000179536.The actual device was received for evaluation.Visual inspection was performed to check for kinks or any occlusions with no issues noted.A dimensional check of the transport tubes and pump segment, and a venous filter inspection were also performed with no issues noted.The customer also 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 prescribed machine settings were: blood flow rate 450 ml/min, dialysate flow rate 800 ml/min.No visible defects were observed in the bloodlines.Approximately forty minutes into treatment, the machine generated a "high pump speed" alarm.Another machine was prepared for treatment and the blood was returned to the patient.After rinse-back, medical staff observed the presence of red blotches on the neck, nose, and behind the ears of the patient.The patient also reported itching, abdominal pain, and nausea.The physician was notified and the patient was prescribed benadryl (dose not provided).After the benadryl was administered, treatment continued without difficulty.The patient was released to home.Later, the patient reported severe abdominal pain and an ambulance was called.The patient was in full arrest upon arrival to the hospital.It was determined that the patient¿s blood was hemolyzed.Following presentation to the emergency room, the patient would intermittently have return of circulation after administration of epinephrine.This occurred three times.Following the third attempt to resuscitate the patient, the life-saving measures were ceased and the patient died.The patient was reported to have undergone an autopsy; however, results are not available at this time.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: 7336630
• MDR Text Key: 102300818
• Report Number: 8030638-2018-00004
• 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 Health Care Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• 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?: Yes
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 66