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

Model Number 8015

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there were defective pcu (8015) keypads resulting in the devices not powering on.There was no patient harm.The issues were noted prior to patient use.

Event Description

It was reported, that there were defective pcu (8015) keypads.Resulting in the devices not powering on.There was no patient harm.The issues were noted, prior to patient use.

Manufacturer Narrative

The reported issue of unresponsive (shorted) keypad is confirmed, based on the field action.The root cause has been determined, to be an electrical failure design.Device history record (dhr) reviews are not required for field action complaints, because the root cause of the issue is known.E3: correction: h3 other text: device was not returned.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11103489
• MDR Text Key: 225341057
• Report Number: 2016493-2020-82437
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2909-2020
• Patient Sequence Number: 1