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

Model Number	10011301
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the set failed to prime due to occlusion in the line was confirmed.Visual inspection under a microscope of the engagement between the check valve inlet port and the pvc tubing identified an obstruction caused by excessive solvent.Functional testing observed that the fluid would not prime the sets.The root cause for the occlusion was identified as excessive solvent being applied during the manufacturing process.
Event or Problem Description
It was reported that the epidural pcea set was attempted to be primed 6 times while in the pacu, however each set failed to prime due to an occlusion in the line.The pain team was notified and the patient was transferred to the icu to determine if their epidural pcea sets would prime.There was no report of patient harm, and there was no distress or increase pain due to the event.

• 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: 8402275
• Report Number: 9616066-2019-00700
• Device Sequence Number: 2326614
• Product Code: FPA
• UDI-Device Identifier: 10885403232541
• UDI-Public: 10885403232541
• 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: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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: 11/14/2020
• Device Model Number: 10011301
• Device Catalogue Number: 10011301
• Device Lot Number: 17117240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1