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

Model Number PRI TUBING

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a site visit by a bd clinical consultant, that near the end of blood transfusions, an ¿occluded container side¿ alarm occurs.The tubing appears flattened inside of the pump module door upon opening the door to inspect the tubing.This is one of at least 3 occurrences.The staff recalls blood remaining in the bag on one occasion and potentially an empty bag with blood in the drip chamber on another occasion.These events occurred in the children¿s hospital outpatient services.

• Brand Name: PRIMARY TUBING SET
• Type of Device: SET, ADMINISTRATION, 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9629934
• MDR Text Key: 191692913
• Report Number: 9616066-2020-00280
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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
• Is the Reporter a Health Professional?: Yes
• 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