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

Model Number	2430-0500
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	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Per customer, the requested information on race and ethnicity is not available.
Event or Problem Description
It was reported that the tubing has a hole and it leaked at the top part of pump segment while priming total parenteral nutrition (tpn) on a sterile field.The set was not connected to the patient.The event occurred in neonatal intensive care unit.There was no significant delay in infusion therapy.
Event or Problem Description
It was reported that the tubing has a hole and it leaked at the top part of the pump segment while priming total parenteral nutrition (tpn) on a sterile field.The set was not connected to the patient.The event occurred in neonatal intensive care unit.It was confirmed during follow up that there was no delay in patient care, and that this event did not contribute to, or result in a serious adverse impact to the infant patient.
Additional Manufacturer Narrative
The customer's report of a hole and leak at the pump segment was confirmed.The set sample was inspected for kinks, holes/tears in the tubing or damages to the components.There was a small tear in the silicone segment directly below the upper fitment component.Fluid was observed leaking from the tear.The set was pressure tested; the fluid within the set leaked from the tear.The observed leak was due to a tear on the silicone segment component.The root cause of the tear was not identified.Device history record for model 2430-0500 lot 20015349 shows that the set was manufactured on (b)(6) 2020 with a total of 7,683 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.

• 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: 9953016
• Report Number: 9616066-2020-01269
• Device Sequence Number: 14157620
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 01/03/2023
• Device Model Number: 2430-0500
• Device Catalogue Number: 2430-0500
• Device Lot Number: 20015349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Weight: 2