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

Model Number	10013361T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported visible residue of hazardous drugs on connecting surfaces upon disconnection when they prepare chemo in their pharmacy 90-100% of the time every day for the past 5 years.There was no patient involvement.
Event or Problem Description
The customer reported visible residue of hazardous drugs on connecting surfaces upon disconnection when they prepare chemo in their pharmacy 90-100% of the time every day for the past 5 years.There was no patient involvement.
Additional Manufacturer Narrative
The photo provided by the customer observed visible residue of fluid on all reported suspect sets.The root cause was not identified.

• Brand Name: ALARIS INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8733080
• Report Number: 9616066-2019-01736
• Device Sequence Number: 2374814
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: 10885403223204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 10013361T
• Device Catalogue Number: 10013361T
• 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: 06/25/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1