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

Model Number	2120-0500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
Event or Problem Description
It was reported that the rn primed the tubing set and initiated the infusion of an unspecified medication.Approximately 10 minutes later, the nurse was called to the patient's room by the patient's mother and found that the tubing set had separated at the upper fitment.The customer later stated that there were no adverse effects caused to the patient.
Additional Manufacturer Narrative
No product will be returned per customer.However; the customer¿s complaint that the tubing set separated at the upper fitment was confirmed.A photo provided by the customer observed that the silicone pumping segment was completely separated from the upper fitment.The set appeared to be completely primed with solution.The root cause of the separation could not be definitively determined.
Event or Problem Description
It was reported that the rn primed the tubing set and initiated the infusion of an unspecified medication.Approximately (10) minutes later, the rn was called to the patient's room by the patient's mother and found that the tubing set had separated at the upper fitment.The customer later stated that there were no adverse effects caused to the patient as a result of this event.

• 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: 9192821
• Report Number: 9616066-2019-02862
• Device Sequence Number: 2409588
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 02/16/2022
• Device Model Number: 2120-0500
• Device Catalogue Number: 2120-0500
• Device Lot Number: 19025482
• 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: 10/15/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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: 8100, 8015, THERAPY DATE (B)(6) 2019