MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10108964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that; there have multiple events in which the extension sets were separating prior to patient use.The iv fluids that are used are generally lactated ringers and sodium chloride for infusions.The iv bags sizes range from 250ml, 500ml & 1000ml depending on age of patients.Customer further stated, there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
A photo of a set was provided by the customer.However, the attached photo does not represent the actual event.No issues were observed.The root cause of this failure was not identified.
Event or Problem Description
It was reported that there have multiple events in which the extension sets were separating prior to patient use.The iv fluids that are used are generally lactated ringers and sodium chloride for infusions.The iv bags sizes range from 250ml, 500ml & 1000ml depending on age of patients.Customer further stated that there were no adverse effects caused to the patient from the event.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9107281
• Report Number: 9616066-2019-02698
• Device Sequence Number: 2430472
• Product Code: FPA
• UDI-Device Identifier: 10885403234149
• UDI-Public: 10885403234149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10108964
• Device Catalogue Number: 10108964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1