MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, I.V. FLUID TRANSFER

Catalog Number ASKU

Device Problems Difficult to Open or Close (2921); Protective Measures Problem (3015); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that an unspecified quantity of exactamix valve sets had bubble formation resulting in alarms on the compounding device.This was observed during setup.The valves did not appear to "close completely".There was no patient involvement.No additional information is available.

Manufacturer Narrative

G1 manufacturing facility - the devices were manufactured at one of the two following manufacturing sites: availmed c.Industrial lt.001 mz.105 no 20905 int a, col cd ind.Tijuana, baja california 22444 mexico baxter healthcare - englewood 14445 grasslands dr englewood, co 80112 united states should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the product information was not available.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; see h10; see h10; see h10
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18085607
• MDR Text Key: 327547426
• Report Number: 1416980-2023-05731
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: Other
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1