MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number 10010903

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

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

The customer reported the set split while being used on a patient.There is no report of patient harm.

Event Description

A partial date of (b)(6) 2018 was reported.

• Brand Name: NON-VENTED BLOOD SET
• Type of Device: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7561388
• MDR Text Key: 110036216
• Report Number: 9616066-2018-00669
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• PMA/PMN Number: K050115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Other Device ID Number: 7613203020879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, THERAPY DATE UNK