MAUDE Adverse Event Report: The Metrix Company BAXTER EVA DUAL CHAMBER BAG 3000 mL

Model Number	63630
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction

• Brand Name: BAXTER EVA DUAL CHAMBER BAG 3000 mL
• Common Device Name: EVA Dual Chamber Bag 3000 mL
• Manufacturer (Section D): The Metrix Company; 4400 chavenelle rd; dubuque IA 52002
• Manufacturer (Section G): Metrix Dominicana; parque industrial itabo; bldg 5; san cristobal, dma ; DR
• Manufacturer Contact: patricia ayers ; 4400 chavenelle rd; dubuque, IA 52002 ; +1(563)556-8800
• MDR Report Key: 50175187
• Report Number: 1937141-2026-00003
• Device Sequence Number: 8281546
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: 00085412477473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: Lay User/Patient
• Device Model Number: 63630
• Device Catalogue Number: 63630
• Device Lot Number: 63630-A8727
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown