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

Model Number	10014855A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the infusion pump noted an air-in-line alarm, and that the pump was leaking was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear fluid was observed within the tubing throughout the set.No damages or anomalies were observed on the pump segment or throughout the set during initial inspection.Functional testing found that the set leaked from the top of the silicone segment.Closer inspection under a lab microscope observed that the leak is due to a small hole on the silicone segment.No damages or tool marks were observed on the pump segment.The source of the air-in-line alarm and leak is due to a small hole damage in the silicone pump segment near the upper fitment.The root cause of the hole damage could not be definitively determined.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "infusion pump alarm noted as air in line, taken out of pump an noted leaking, noted hole below first blue part of tubing." an incomplete event date of (b)(6) 2019 was provided.The event occurred in pediatric icu (picu).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: 9246787
• Report Number: 9616066-2019-02999
• Device Sequence Number: 3935233
• Product Code: FPA
• UDI-Device Identifier: 10885403232619
• UDI-Public: 10885403232619
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 10014855A
• Device Catalogue Number: 10014855A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1