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

Model Number	10927766
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported a bulge in the silicone segment of the tubing shortly after starting the infusion and after the pump alarmed.The tubing was connected to a patient.There was no patient harm.
Additional Manufacturer Narrative
The customer's report of a bulge in the silicone segment was confirmed.Visual inspection of the set showed that the silicone segment tubing had a ballooned bulge near the upper fitment.Functional testing showed no anomalies.The root cause of the balloon/bulge in the silicone segment was identified as an iv push medication or flush being executed below the pump without first clamping the tubing above the injection port.
Event or Problem Description
The customer reported a bulge in the silicone segment of the tubing shortly after starting the infusion and after the pump alarmed.The tubing was connected to a patient.There was no patient harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7824737
• Report Number: 9616066-2018-01498
• Device Sequence Number: 16537444
• Product Code: FPA
• UDI-Device Identifier: 07613203019101
• UDI-Public: 7613203019101
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 08/07/2018

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 Expiration Date: 02/26/2021
• Device Model Number: 10927766
• Device Catalogue Number: 10927766
• Device Lot Number: 18026852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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: 8100,8015, TD
• Patient Weight: 75