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

Model Number	41137E
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 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 that the ambulatory care department experienced a tubing set that separated at the drip chamber and leaked during patient use.There was no report of patient harm.
Event or Problem Description
The customer reported that the ambulatory care department experienced a tubing set that separated at the drip chamber and leaked during patient use.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing set separated at the drip chamber and leaked was confirmed.Received from the customer as one used drip chamber; the tubing and remaining components of the set below the drip chamber were not received from the customer visual inspection under a magnification observed insufficient solvent on the connection of the tubing to the drip chamber.Functional testing was not performed on the received drip chamber due to the missing tubing and components.Dimensional testing was performed on the drip chamber tubing connection area.All sample measurements were within specifications.The root cause of the reported separated tubing at the drip chamber and leaking was insufficient solvent between the connecting engagement of the set¿s tubing and drip chamber.

• Brand Name: ALARIS® GRAVITY ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8228687
• Report Number: 9616066-2019-00014
• Device Sequence Number: 11199058
• Product Code: FPA
• UDI-Device Identifier: 10885403235290
• UDI-Public: 10885403235290
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 12/12/2018

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: 41137E
• Device Catalogue Number: 41137E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1