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

Catalog Number 101025

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Awaiting update to include sample analysis.

Event Description

A patient was undergoing dialysis treatment with a cartridge bloodline when a blood leakage was observed due to a break at the level of the cartridge.The leak was identified approximately one hour and forty-seven minutes before the end of the treatment.The customer estimated that the blood loss was more than 150ml.Treatment was interrupted without returning the blood back to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there was no deviation found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation.However, the customer provided three pictures which were visually inspected.The inspection identified a leakage originating from the cartridge arterial pod.The reported condition was verified.The cause of the condition was not determined.Eight retained samples from the same lot were visually inspected.No deviations or damages were observed during the inspection of the retained samples.Simulated use testing and leak testing under water were performed on the eight retained samples with no anomalies observed.The retention samples were found to operate per specification.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 california
• MDR Report Key: 7549801
• MDR Text Key: 109513821
• Report Number: 8030638-2018-00005
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Catalogue Number: 101025
• Device Lot Number: 1000180149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR