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

Model Number	2429-0500
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, patient demographics not provided.Concomitant medical products: 250ml baxter bag, lot dr18f15096, intravia container.The customer¿s report of a leak was confirmed.Functional testing observed leakage from the top of the silicone segment.Closer inspection under magnification observed a leak due to a small hole on the silicone segment.No tool marks or crush marks were observed on the upper fitment near the small hole.The cause of the leak is a small hole damage in the silicone pump segment near the upper fitment.The root cause of the hole damage could not be definitively determined.
Event or Problem Description
The set was received unexpectedly with a report that it leaked, potentially from a crack or flush.Although requested, no further information was 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: 8356401
• Report Number: 9616066-2019-00323
• Device Sequence Number: 2197993
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 08/08/2021
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 18085690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1