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

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	04/30/2019
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 sequestered for failure investigation.The root cause of this failure was not identified.Not hispanic/latino; al amyloidosis.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "initiated patient infusion registered nurse (rn) responded to alarm on alaris pump "air in line".Resolved issue and restarted the pump.Pump alarmed "air m line" for the second time rn checked iv tubing and at that time the iv tubing detached from the plastic connection at the chamber portion of the tubing." an incomplete date of event of (b)(6) 2019 was provided.It was reported daratumumab/saline was initiated at an unspecified rate.The device alarmed for air in line, the user noticed that the tubing separated at the lower fitment.The customer confirmed that there was no patient harm as the fluids did not go thru the length of the tubing.

• Brand Name: ALARIS PUMP ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8755412
• Report Number: 9616066-2019-01774
• Device Sequence Number: 11272144
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 02/08/2022
• Device Model Number: 2120-0500
• Device Catalogue Number: 2120-0500
• Device Lot Number: 19025481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68