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

Catalog Number 2N3326

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 03/31/2016

Event Type  Injury  

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5657409
• MDR Text Key: 45246685
• Report Number: 1416980-2016-09124
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 2N3326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention