MAUDE Adverse Event Report: CAREFUSION ALARIS PC UNIT; PUMP, INFUSION

Model Number 8015

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the bezels, doors, and latches break too often.No patient involvement was reported in this event.

Manufacturer Narrative

Disregard file (after further review, the device is not a suspect).

Event Description

It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the bezels, doors, and latches break far too often.No patient involvement was reported in this event.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10117257
• MDR Text Key: 194142113
• Report Number: 2016493-2020-01223
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K091308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1