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

Model Number PRI TUBING

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the iv tubing ballooned at the pumping segment.The lines and the pumps were changed out.

• Brand Name: PRIMARY TUBING SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9847543
• MDR Text Key: 188881270
• Report Number: 9616066-2020-00968
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1