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

Model Number	10014916
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.
Event or Problem Description
The customer reported a clogged lipid filter extension set, when the rn was checking the patient lines a leak/moisture was noted from the extension set.There was no report of patient harm.The event occurred in the (b)(6).
Additional Manufacturer Narrative
The customer¿s report of a filter extension set leaking was confirmed.Visual inspection of set noted no damage or any anomalies.Functional testing confirmed leaking from the of the filter outlet where the tubing and filter meet.The tubing was measured to be within measurement specification.The root cause of the customer¿s report of leaking from the filter was due to insufficient solvent at the engagement between the filter outlet and tubing.
Event or Problem Description
The customer reported a leak from the filter extension set during a lipid infusion in the nicu.The leak appeared to be caused by a clogged filter.Although requested the customer did not indicate patient harm.

• 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: 8076392
• Report Number: 9616066-2018-02250
• Device Sequence Number: 1721670
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 11/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: (2)PRI TUBING,8110,8015,SYRINGE, TD (B)(6) 2018; 20129E,10014914, THERAPY DATE (B)(6) 2018
• Patient Age: 11 DA