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

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
The customer reported that the user noticed a wet spot on the patient's blanket near the iv lines during a continuous infusion of versed.It was reported that a wet spot was noted 2 days prior.The user applied a gauze under the disc to determine the location of the leak and confirm that the fluid was coming from the filter.At both times the iv lines were changed.The facility went live a couple of months with the filter set however in the past 2 weeks the nicu has noticed several filter extension set complaints.Although requested the customer did not indicate any patient harm.The event occurred in the nicu.
Event or Problem Description
It was reported that the customer noticed a wet spot on the patient's blanket near the iv lines during a continuous infusion of versed in the nicu.A similar leak was identified 2 days prior; both times the lines were changed.The user applied a gauze under the disc to determine the location of the leak and confirmed that the fluid was coming from the filter.The facility went live a couple of months ago with the filter set, however in the past 2 weeks the nicu has noticed several filter extension set leaks and complaints.Although requested the customer did not indicate any patient harm, nor were further details or information given regarding this event.
Additional Manufacturer Narrative
The customer¿s report of a filter leak was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in no leaking and no signs of occluding.The root cause of the customer¿s report was not be identified.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8244738
• Report Number: 9616066-2019-00048
• Device Sequence Number: 11260384
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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: 8015,(2)SYR TUBE,8110,(2)SYRINGE, TD (B)(6) 2018.; 8015,(2)SYR TUBE,8110,(2)SYRINGE, TD (B)(6) 2018