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

Model Number	10879047
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of a kinked tubing was not confirmed; however, the issue of inability to prime the set was confirmed.Visual inspection showed no related issues.The check valve orientation was correct and there was no visible material within the set that could cause an occlusion.No kinks were observed.Functional testing was performed and the set was unable to be primed any further than it had been upon receipt.From previously investigated complaints for this same failure mode, the root cause of the reported issue is material degradation and/or deformation within the fluid path of the check valve.
Event or Problem Description
The customer reported issues with tubing where sets kinked and were unable to prime.For one instance, a patient¿s blood pressure had dropped to 52 and the clinician was attempting to prime the tubing to start a new medication.The difficulty priming resulted in a delay until new tubing was obtained.The set was not attached to the patient at the time of the event.No patient harm was reported and the set was sequestered.

• 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: 8248571
• Report Number: 9616066-2019-00127
• Device Sequence Number: 1558336
• Product Code: FPA
• UDI-Device Identifier: 10885403232275
• UDI-Public: 10885403232275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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
• Report Date (Section B): 07/27/2018

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: 02/01/2021
• Device Model Number: 10879047
• Device Catalogue Number: 10879047
• Device Lot Number: 18025226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1