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

Catalog Number 101025

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately one hour into treatment with cartridge blood lines, an external blood leak occurred from the seal between the two halves of the cartridge.The amount of blood loss was not provided.The patient was fully awake, conscious and was taken off from treatment.However, the patient was feeling lightheaded and after blood pressure reading, saline was administered.It was reported that the patient was sent to the hospital via ambulance.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the actual device was not available; however, a drawing was provided for evaluation indicating that the leakage occurred at the side of venous chamber.According to the reported condition, an external blood leak occurred from the seal between the two halves of the cartridge.The reported condition was verified.The cause was attributable to the manufacturing (i.E.Molding process).A nonconformance has been opened to address this issue.The lot number was unknown; therefore, a batch review could not be performed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Corrected information added to b1, b2 and h1.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 CORPORATION; deerfield IL
• MDR Report Key: 12332353
• MDR Text Key: 266936925
• Report Number: 8030638-2021-00017
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention