MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EVA DUAL CHAMBER CONTAINER 3L; CONTAINER, I.V.

Catalog Number	H938905
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred from (b)(6) 2020 up to present.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was difficulty in closing the clamps of an unspecified quantity of exactamix 3000 ml dua l-chamber eva bags.It was further reported that when closing the clamps, pieces of plastic break off inside the hood.This issue was identified during setup prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, five (5) companion samples were received for evaluation.The five (5) samples were opened and visually inspected and no clamp damage was observed.The clamps were however closed with difficulty.The reported condition in difficulty closing the clamps was verified; however not confirmed for damaged clamps.The cause of the difficulty closing clamps was found to be due to a manufacturing related issue.This issue was further investigated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVA DUAL CHAMBER CONTAINER 3L
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10563379
• Report Number: 1416980-2020-05869
• Device Sequence Number: 11472135
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: (01)00085412477473
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: Other
• Device Expiration Date: 02/24/2025
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A5951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1