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

Model Number	11590100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: central line.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.Although requested, patient demographics was not provided.Patient is a neonate as the event occurred in neonatal intensive care unit.
Event or Problem Description
It was reported that the nurse found a puddle of fluid on the floor.The tubing was then inspected and found a hole where the leak was coming from.Total parenteral nutrition (tpn) was infusing through a central line at the time of the event.There was a delay in infusion therapy due to changing of intravenous fluid.The patient was then checked for infection and there was no patient harm.The event occurred in neonatal intensive care unit (nicu).
Event or Problem Description
It was reported that the nurse found a puddle of fluid on the floor.The tubing was then inspected and found a hole where the leak was coming from.Total parenteral nutrition (tpn) was infusing through a central line at the time of the event.There was a delay in infusion therapy due to changing of intravenous fluid.The patient was then checked for infection and there was no patient harm.The event occurred in the neonatal intensive care unit (nicu).
Additional Manufacturer Narrative
The customer¿s report that the tubing had a hole and leaked was confirmed.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted clear liquid within the tubing throughout the each set.No damages were observed on the upper or lower fitment or throughout the set.Functional testing confirmed leaking from a small hole at the top of the silicone segment near the upper fitment.The root cause of the customer¿s report could not be 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: 9787435
• Report Number: 9616066-2020-00657
• Device Sequence Number: 19527630
• Product Code: FPA
• UDI-Device Identifier: 10885403232411
• UDI-Public: 10885403232411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 11590100
• Device Catalogue Number: 11590100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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,CUROS CAP,NON-BD EXT SET, TD (B)(6) 2020.