MAUDE Adverse Event Report: CAREFUSION ALARIS® GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	42405E-07
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint of a leak during patient use could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that while attached to the patient, the set came apart at the stopcock and leaked.There was no patient harm.

• Brand Name: ALARIS® GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7714994
• Report Number: 9616066-2018-01122
• Device Sequence Number: 1316586
• Product Code: FPA
• UDI-Device Identifier: 10885403238611
• UDI-Public: 10885403238611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 42405E-07
• Device Catalogue Number: 42405E-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1