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

Model Number	2435-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Requested patient demographics however decline to answer.Lot not provided.
Event or Problem Description
It was reported that the new tubing leaked saline at upper fitment.The customer confirmed that there was no patient harm.There was no additional event details provided at this time.
Additional Manufacturer Narrative
The customer's report of a leak at upper fitment was confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted tear in the silicone segment directly below the upper fitment component.No other damage or issue was observed.Functional testing confirmed leaking from the tear.The cause of the leak was due to a tear on the silicone segment component.The root cause of the damage was not identified.
Event or Problem Description
It was reported that the new tubing leaked saline at the upper fitment.The customer confirmed during follow up that there was no patient harm as a result of this event.Although requested, there was no additional event details provided at this time.

• 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: 9437268
• Report Number: 9616066-2019-03542
• Device Sequence Number: 297384
• Product Code: FPA
• UDI-Device Identifier: 10885403220906
• UDI-Public: 10885403220906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/18/2019

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 Model Number: 2435-0007
• Device Catalogue Number: 2435-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: 1000ML BAXTER BAG, THERAPY DATE (B)(6) 2019.