MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS EXTENSION SET; NONE

Model Number 20022

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the set split in half at the middle section of the set during infusion.There was no patient harm or medical intervention.No further patient/event information was reported.

Manufacturer Narrative

(b)(4).Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: NONE
• Manufacturer (Section D): CAREFUSION CORPORATION; san diego CA
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa bldg.; san diego, CA 92121 ; 8586176477
• MDR Report Key: 3937318
• MDR Text Key: 4576003
• Report Number: 9616066-2014-00369
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/28/2014

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: 20022
• Device Catalogue Number: 20022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2014
• Initial Date FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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