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

Model Number	10013072
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that the iv tubing set leaked between the male luer and the baxter filter during an epoch infusion at a rate of 20.8 ml for 6 hours.There was no patient impact.
Event or Problem Description
It was reported that the iv tubing set leaked between the male luer and the baxter filter during an epoch infusion, at a rate of 20.8ml for (6) hours.The leak only went on the bed linen.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Continued from d.11: non-bd syringe adapter;non-bd extension set;curos cap; spiros adapter attached to male luer; td (b)(6) 2020.Additional information added; section; b.5.(patient/event information clarified/detailed), and h.6.(patient code).The customer¿s report that the iv tubing set leaked between the male luer and the baxter filter was not confirmed.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Light pink fluid was observed throughout the sets¿ tubing.No anomalies or initial visible damages were observed with any of the sets¿ components or throughout the sets.Functional testing did not observe any leaks or issues with the administration set.Pressure testing also found no anomalies.Model's male luer port was measured and found to be within iso standards.The root cause of the customer's report could not be identified.
Event or Problem Description
It was reported that the iv tubing set leaked between the male luer and the baxter filter during an epoch infusion, at a rate of 20.8ml for (6) hours.It was further confirmed during follow up, that there was no patient involvement and subsequently, no patient harm or impact as a result of this event.

• 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: 9674901
• Report Number: 9616066-2020-00324
• Device Sequence Number: 19428899
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 01/15/2020

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 Model Number: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/24/2020; 04/07/2020
• 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: 8100,8015, TD 01/12/2020