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

Model Number	2452-0007
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
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.
Event or Problem Description
It was reported that the leak was from the blue plastic that inserts into the pump segment.It did not appear to be cracked.No patient harm was reported.
Additional Manufacturer Narrative
The customer¿s report of leak from the lower pumping segment was confirmed based on visual inspection.Further inspection and comparison identified that the incorrect tubing type was attached to the set¿s lower fitment component.The separation was at the engagement between the lower fitment and expected pvc tubing components.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No other damages or issues were observed.Testing was deemed unnecessary due to the obvious separation.The root cause of the separation and leak is a manufacturing issue due to assembly of an incorrect component.
Event or Problem Description
It was reported that the leak was from the blue plastic that inserts into the pump segment.It did not appear to be cracked.It was further confirmed during follow up, that there was no patient harm as a result of this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9123607
• Report Number: 9616066-2019-02746
• Device Sequence Number: 2460053
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 03/12/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19035914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1