MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE EM1200 VALVE SET; SET, I.V. FLUID TRANSFER

Catalog Number	H938792
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 4 malfunction events.It was reported that four (4) exactamix 1200 valve sets disconnected during compounding, leading to a leak.The reporter stated that the tubing set end has ¿blown off¿ the final bag.There was no patient involvement.No additional information is available.

• Brand Name: EM1200 VALVE SET
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• MDR Report Key: 8831721
• Report Number: 1416980-2019-04051
• Device Sequence Number: 2586857
• Product Code: LHI
• UDI-Device Identifier: 00085412477305
• UDI-Public: (01)00085412477305
• Combination Product (Y/N): N
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: H938792
• Device Lot Number: 60159898
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1