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	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: syringe, therapy date (b)(6) 2018.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 at filter leak when infusing tpn.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a filter leak was confirmed.Visual inspection of the set noted no damage or any anomalies.Examination under magnification did not observe any gaps at the microbore tubing to filter outlet engagement and the tubing remained securely attached following a ¿tug¿ test.Functional testing confirmed leaking at the microbore tubing to filter outlet engagement.During additional flush tests the liquid movement was noted between the outer wall of the tubing and the inner wall of the filter outlet port, indicating a solvent channel.Dimensional testing was performed and the microbore tubing was within the outer diameter tubing specification.The cause of the leak was identified as insufficient/lack of solvent being applied at the affected engagement.The root cause of the insufficient/lack of solvent is attributed to improper assembly due to equipment and/or operator error.
Event or Problem Description
The customer reported a filter leak when infusing tpn.There was no report of 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: 8078285
• Report Number: 9616066-2018-02269
• Device Sequence Number: 13782590
• 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): 10/11/2018

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: 10/25/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: 8110,8015,EXT TUBING,MZ1000-07, TD (B)(6) 2018; 8110,8015,EXT TUBING,MZ1000-07, TD (B)(6) 2018