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

Model Number 8100

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient demographics requested however customer decline to provide.No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the user stated that the device alarmed for error codes during frequent channel disconnects.The customer reported that there was no patient harm.The facility biomed team performed testing and there were no problems found with the device or could not replicate the issue.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8584776
• MDR Text Key: 145641127
• Report Number: 2016493-2019-00482
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403222054
• UDI-Public: 10885403222054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2019

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
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1