MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE EVA DUALCHAMBER CONTAINER 1.5L; CONTAINER, I.V.

Catalog Number	H938901
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an exactamix 1500 ml dual-chamber eva bag was leaking from an unspecified location prior to use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The actual device was not available; however, photographs of the sample were provided for evaluation.A visual inspection of the photographs revealed that the eva dual chamber bag was leaking from where the clamp separates the two chambers of the bag.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVA DUALCHAMBER CONTAINER 1.5L
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• MDR Report Key: 8111599
• Report Number: 1416980-2018-07486
• Device Sequence Number: 1693932
• Product Code: KPE
• UDI-Device Identifier: 00085412477466
• UDI-Public: (01)00085412477466
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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 Expiration Date: 11/20/2022
• Device Catalogue Number: H938901
• Device Lot Number: 63615-A2658
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 01/02/2019; 05/01/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/29/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1