MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Type  malfunction  

Manufacturer Narrative

Age: baby.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported when connecting this tubing up to the tpn.The tubing pulled away from the drip chamber which allowed all the fluid to spill.The patient was not able to get the nutrients required.

Manufacturer Narrative

Additional information added; section; b.5.(patient information clarified/detailed), and h.6.(device code).The customer¿s report that the tubing separated from the drip chamber was confirmed of the received partial primary set model and lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.The separation was determined to be at the engagement between the upper fitment and silicone segment tubing.Dimensional analysis of the upper fitment observed dimensions to be within specification(s).Functional testing was not performed due to the separation, missing components, and the leak that would occur.The separation was determined to be at the engagement between the upper fitment and silicone segment.The root cause of the separation could not be definitively determined.

Event Description

It was reported from the (nicu) that when connecting the primary tubing set to the (tpn), the tubing separated from the drip chamber.This allowed all the fluid to spill.The patient was not able to get the nutrients required.Although requested, there has been no further impact to patient response, other than the lack of nutrients, or any additional event information made available to date.

• Brand Name: PRIMARY TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9690726
• MDR Text Key: 191557680
• Report Number: 9616066-2020-00438
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1