FDA Adverse Event Malfunction Summary report: N

8015 ALARIS SYSTEM PC UNIT

MDR report key: 10894717 · Received November 24, 2020

Report

Report Number: 2016493-2020-47891
Event Type: Malfunction
Date Received: November 24, 2020
Report Date: September 20, 2018
Manufacturer: CAREFUSION SD
Product Code: FRN
UDI-DI: 10885403801518
PMA / PMN Number: K133532
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem · 1

(B)(4). CUSTOMER CALLED IN FOR HELP ON 8015 UNIT BRAND NEW THEY GOT IN ONE MONTH AGO GET ERROR CODE 100-1250 WHICH IS THE MAIN SAFETY SYSTEM & OPTION BOARD UNKNOWN ERROR CUSTOMER WILL SEND UNIT IN FOR SERVICES REPAIR. TRANSFER CUSTOMER TO SERVICES REPAIR DESK TO GET UNIT SETUP FOR REPAIR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1361635	8015 ALARIS SYSTEM PC UNIT	PUMP, INFUSION	FRN	CAREFUSION SD	8015		10885403801518

Patients

Seq	Age	Sex	Outcome	Treatment
1