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

Catalog Number 103401

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional information become available a supplemental report will be submitted.

Event Description

It was reported that an external blood leakage occurred during treatment with a cartridge bloodline.The leakage was observed at the heparin line approximately 30 minutes after starting patient treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample and eight retained samples were evaluated.Visual inspection of the retention samples did not identify any abnormalities that could have contributed to the reported condition.The samples were leak tested under water.No abnormalities were identified from the retention samples that could have contributed to the reported condition.The visual inspection of the provided picture showed the location of the leak at the connection between the heparin line and the female luer connector.From the picture analysis, it was not possible to identify any presence of damages between the line and the female luer connector.A device history review revealed no issues that could have caused or contributed to the reported issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was not determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD EITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 8126365
• MDR Text Key: 129355000
• Report Number: 8030638-2018-00024
• Device Sequence Number: 1
• Product Code: FJK
• 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: 12/28/2018

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 Catalogue Number: 103401
• Device Lot Number: 1000192741
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1