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

Catalog Number H938905

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified number of exactamix 3000 ml dual-chamber eva bag clamps would "not line up and clamp".It was further reported that when trying to close the clamps, the clamp would crack.This was identified during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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: EVA DUAL CHAMBER CONTAINER 3L
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11088170
• MDR Text Key: 224305759
• Report Number: 1416980-2020-08134
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): Y
• PMA/PMN Number: K960581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938905
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1