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

Catalog Number 103401

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an external blood leak was observed on a gambro cartridge dialyzer, due to a broken vein chamber of the c-3 tubing.The event was observed after use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h2, h6 and h10.H10: the actual device was not available; however one reference picture was provided for evaluation.The visual inspection of the picture confirmed that an external blood leak occurred on the venous chamber near of the cartridge port.The reported condition was verified.Eight retention samples were visually inspected and leak tested and they met the quality acceptance criteria.The most likely cause is related to the assembling process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.D4: the involved lot number is 1000266031 and not 100026031, as initially reported.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: 11230540
• MDR Text Key: 239252751
• Report Number: 8030638-2021-00001
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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: 1000266031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1