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

Model Number	10012144
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that the tubing separated at the upper y-site.When this occurred during the infusion, the rest of the product kinked in the pump which trapped the medication inside the tubing.Although requested, no further information has been received.
Additional Manufacturer Narrative
No product will be returned.The photo provided by the customer shows separation from the pvc tubing to the inlet port of the smartsite.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the tubing separated at the upper y-site.When this occurred during the infusion, the rest of the product kinked in the pump which trapped the medication inside the tubing.Although requested, no further information has been received.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8448917
• Report Number: 9616066-2019-00794
• Device Sequence Number: 16875514
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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 Expiration Date: 12/13/2021
• Device Model Number: 10012144
• Device Catalogue Number: 10012144
• Device Lot Number: 18125884
• 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: 03/25/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100, THERAPY DATE (B)(6) 2019; 8015,8100, THERAPY DATE (B)(6) 2019