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

Model Number	2452-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.Although requested, information was not provided.
Event or Problem Description
It was reported that the set has hole, and an unspecified fluid leaked.The event occurred in the anesthesia department, and it was reported that there was no known harm as a result of this event.
Event or Problem Description
It was reported that the set has a hole, and an unspecified fluid leak.The event occurred in the anesthesia department.It was further reported that there was no patient harm as a result of this event.
Additional Manufacturer Narrative
Additional information added; d.10.************************************** the customer's report that the set has hole and fluid leaked was confirmed.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.There was a v-shaped cut on the tubing approximately five inches below the second smartsite port.The cut was visually inspected under magnification.Each side of the v-shaped cut was measured as approximately 0.1 inches in length.Although damage was observed, the set was reprimed.Fluid leaked from the cut.The cause of the leak was due to the observed cut along the tubing.The root cause of the damage was not identified.

• 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: 9438997
• Report Number: 9616066-2019-03570
• Device Sequence Number: 3282454
• 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): 11/19/2019

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: 08/27/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19087729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• 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: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1