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

Model Number 11607704

Device Problems Backflow (1064); Reflux within Device (1522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

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 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
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9366508
• MDR Text Key: 168698896
• Report Number: 9616066-2019-03450
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1