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

Catalog Number ASKU

Device Problems Disconnection (1171); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Facility name: (b)(6) health centre of (b)(6) dialysis unit.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.The phoenix operator's manual warns the user about reducing the risk of needles disconnection by ensuring that the venous needle and line are firmly secured to the access site area according to facility protocol; to ensure that the patient's access is visible at all times during the dialysis treatment; to inspect frequently the patient's access.The manual also instructs the user to only use accessories and disposables tested and validated with the phoenix machine.Warning "this manual contains a number of references to accessories and disposables for use with the phoenix machine.The phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual.The manufacturer has not validated the use of accessories or disposables other than those specified in this manual.The manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual.It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance." should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at an unknown time during pediatric treatment using a cartridge and a phoenix control unit, the patient's arterial line which was connected to a third-party accessory connector became partially disconnected resulting in a blood loss observed "on the floor beneath the patient".The third-party connector had a leak and at some point (possibly when blankets were moved) became completely disconnected form the arterial bloodline.There were no alarms triggered by the phoenix control unit.No clinical symptoms were reported, however, a code blue was called and the patient was transferred to the pediatric intensive care unit where 2-3 units of blood and other unspecified fluids were administered.The patient was reported to be "fine" and was able to resume dialysis treatment the next day.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 CORPORATION; deerfield IL
• 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: 10616701
• MDR Text Key: 209599483
• Report Number: 8030638-2020-00013
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/02/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention