MAUDE Adverse Event Report: CAREFUSION SD 8015 ALARIS SYSTEM PC UNIT; PUMP, INFUSION

Model Number 8015

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This reported event and any subsequent repairs have been investigated through the normal tsc troubleshooting process.A review of the source device service history record was performed beginning from the date of manufacture to the present date and indicated that this device has been previously returned for service.The database showed no quality notifications were opened for the source device.A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed that this device was involved in a servicing failure which correlates to the customer reported issue.The trackwise complaint history review was completed and it was confirmed that multiple complaints were received with similar sn (b)(4).We will continue to monitor all complaints and failure modes for upward trending and take appropriate action as required.Capa reference: (b)(4).The customer stated that there was no patient involvement.

Event Description

(b)(4).(b)(6) had a pcu8015 power up very slow.It took 10-20 seconds to boot up.I told him if it could be software or logic board issue.He will send the unit in for level 1 repair.

• Brand Name: 8015 ALARIS SYSTEM PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: dinesh thewar paraman ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10611075
• MDR Text Key: 222204106
• Report Number: 2016493-2020-16036
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091308
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• 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