MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8399

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A neonatal patient experienced two small pulmonary artery air emboli while connected to a baxter one-link device.The one-link device was in use as part of an infusion line set up which was connected to the patient¿s central line (no further detail was provided).The cause of the air emboli was unknown.It was reported that ¿a double lumen uvc¿ was inserted into a neonatal patient.Two days after the insertion (catheter), the patient experienced two small air emboli in the pulmonary artery system.The facility¿s air embolism algorithm was initiated which included a complete change of the line set up, proximal to the central line, and repeat imaging for size and position.No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.

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 received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed by, spiking the set into an in-house 1000ml solution bag containing reverse osmosis water.The set was re-primed per label copy and checked for leaks and air in-line.The sample primed normally with no leaks or air noted in-line.No leaks or air ingress was noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6857503
• MDR Text Key: 85751184
• Report Number: 1416980-2017-07299
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: 7N8399
• Device Lot Number: UR17B01062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CLEARLINK SOLUTION SET, 2H8480; CLEARLINK SOLUTION SET, 2N8341; DOUBLE LUMEN UVC (UNSPECIFIED)
• Patient Outcome(s): Required Intervention