MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO INTERLINK SYSTEM T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3326
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
A neonatal patient experienced blood loss due to an interlink connector disconnecting from an unknown site.The cause of the disconnection was not reported.An infant in the neonatal intensive care unit (nicu) was receiving an intravenous (iv) infusion with an interlink extension set.The infant was being treated for cytomegalo virus with an unknown medication.The infant was swaddled and the iv site was peripheral.It was reported that when an unspecified monitor went off, the nurse unwrapped the infant and noticed that the connection between the slip lock (interlink connector) and the iv access was disconnected.The product from which the interlink connector disconnected was unknown.As a result of the disconnection, the infant lost 10-15 cc's of blood and had to undergo multiple transfusions (unspecified number).The end outcome was stated to be good, and the infant recovered from the blood loss.No additional information is available.

• Brand Name: INTERLINK SYSTEM T-CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• MDR Report Key: 5657409
• Report Number: 1416980-2016-09124
• Device Sequence Number: 9451869
• Product Code: FPA
• Combination Product (Y/N): N
• PMA/510(K) Number: K060074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Type of Report: Initial
• Report Date (Section B): 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Catalogue Number: 2N3326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2016
• Initial Report FDA Received Date: 05/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention