MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NOVALINE AK98 TUBING SET FOR HEMODIALYSIS; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number BL 11 SAP CODE 955554

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

"microbubbles/small air in arterial line of novaline (ak98 machine cartridge).Not from patient vascath.Another hd staff reconnected the line to make sure not operator error.Air still seen in arterial line.Seems like air is collected/trapped in dialyzer or venous chamber and not reaching patient via venous line.Baxter product complaint line called, spoke with (b)(6).They will send sample return kit so we can send back novaline to them for review." fda safety report id# (b)(4).

• Brand Name: NOVALINE AK98 TUBING SET FOR HEMODIALYSIS
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 12953706
• MDR Text Key: 281937488
• Report Number: MW5105863
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 06948082702105
• UDI-Public: (01)06948082702105
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: BL 11 SAP CODE 955554
• Device Lot Number: 2001010714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White, Native Hawaiian Or Other Pacific Islander