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	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that the tubing set leaked at the filter site shortly after being primed and hung on the patient.There was no patient harm.
Event or Problem Description
The customer reported that the tubing set leaked at the filter site shortly after being primed and hung on the patient.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of a leak was not confirmed.Visual inspection showed no anomalies.Functional and pressure testing showed no anomalies.The root cause of the customer¿s report could not be determined.

• 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: 8062457
• Report Number: 9616066-2018-02210
• Device Sequence Number: 16508919
• 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
• Report Date (Section B): 10/17/2018

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: 10798696
• Device Catalogue Number: 10798696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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)8110, TD (B)(6) 2018; SYRINGE
• Patient Age: 1 MO
• Patient Weight: 2