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

Model Number	10013072
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the tubing set separated and leaked was confirmed from a picture received by the customer.The customer¿s photo was evaluated and the reported event of separation was observed to be from the nitro tubing to the lower fitment.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that on the 4th floor chemotherapy unit, the rn primed the tubing set per their policy with leucovorin without difficulty.Once primed, the nurse attached the tubing to the patient and placed the tubing set into the alaris pump per facility protocol.After the pump door was closed the tubing separated below the blue safety clamp and leaked a small amount of leucovorin onto the user's chemotherapy gown and the floor, but not the patient.There was no patient harm.

• 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: 8366818
• Report Number: 9616066-2019-00425
• Device Sequence Number: 13858211
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 10013072
• Device Catalogue Number: 10013072
• 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: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1