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

Model Number	10798696
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that the 0.2 micron filter used for a tpn infusion leaked on a premature patient in the neonatal intensive care unit.This event did not harm or impact the patient.
Event or Problem Description
It was reported that the 0.2 micron filter used for a total parenteral nutrition (tpn), infusion leaked on a premature patient in the neonatal intensive care unit (nicu).It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Short description revised to remove hospital case number.
Additional Manufacturer Narrative
Additional information added; d.10.Correction: d.11; e.2, e.3 & e.4.*************************************** the customer's report of a filter leak was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.Visual inspection under magnification of the leaking engagement observed a gap within indicating that the tubing was not fully inserted.During functional testing there was a leak at the engagement of the microbore tubing to the inlet of the filter.Dimensional analysis of the tubing's outer diameter was within specification(s).The root cause was identified as a gap (tubing not fully inserted into filter component) due to operator error during set assembly.
Event or Problem Description
It was reported that the 0.2 micron filter used for a total parenteral nutrition (tpn), infusion leaked on a premature patient in the neonatal intensive care unit (nicu).It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.

• Brand Name: ALARIS SYRINGE MODULE SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9589081
• Report Number: 9616066-2020-00156
• Device Sequence Number: 3175649
• Product Code: FPA
• UDI-Device Identifier: 10885403234354
• UDI-Public: 10885403234354
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 12/30/2019

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: 10798696
• Device Catalogue Number: 10798696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 03/11/2020; 04/04/2020
• 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: 8110,8015, TD (B)(6) 2019; PRI TUBING,8100, TD (B)(6) 2019
• Patient Weight: 2