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

Model Number	11607704
Medical Device Problem Codes	Backflow (1064); Reflux within Device (1522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, section was not provided by the customer.The customer report that carboplatin free-flowed down into the primary bag was not confirmed or replicated during testing.Internal and external inspection was performed and no issues were found that would have contributed to the customers reported free flow event.The customer did not return the administration sets in use at the time of the event therefore no testing could be performed.The customer reported that no infusion had been started so no log review was performed.Timed rate accuracy testing was performed and the device was within specification.During testing there were no periods of unregulated flow observed or the condition described where the secondary fluid back flowed into the primary bag.The root cause was not determined.
Event or Problem Description
It was reported that after hooking up the secondary infusion of carboplatin and opening the clamp it free-flowed down into the primary bag which was hung lower than the secondary.The pump was not started yet.The patient did not receive any medication.They changed all the tubing and it happened again so they changed the pump and it flowed normally.There was no patient impact.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9366508
• Report Number: 9616066-2019-03450
• Device Sequence Number: 2432256
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

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: 11607704
• Device Catalogue Number: 11607704
• 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: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1