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
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 12953706
• Report Number: MW5105863
• Device Sequence Number: 5424466
• Product Code: FJK
• UDI-Device Identifier: 06948082702105
• UDI-Public: (01)06948082702105
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White, Native Hawaiian Or Other Pacific Islander