FDA Adverse Event Malfunction Summary report: N

8015 ALARIS SYSTEM PC UNIT

MDR report key: 10558763 · Received September 21, 2020

Report

Report Number: 2016493-2020-09702
Event Type: Malfunction
Date Received: September 21, 2020
Report Date: January 23, 2018
Manufacturer: CAREFUSION SD
Product Code: FRN
PMA / PMN Number: K091308
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THIS REPORTED EVENT AND ANY SUBSEQUENT REPAIRS HAVE BEEN INVESTIGATED THROUGH THE NORMAL SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS USED INFORMATION, WAS REVIEWED FOR THE SAP FILE AND TRACK WISE FILE, AND FOUND TO BE RELEVANT TO THE SERVICE REPAIR. 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 NOT 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 NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem · 1

(B)(6) 2018 12:17:02 (B)(6). WAR: PO: (B)(6). SHIPPING & BILLING ADDRESSES CONFIRMED. NPI. (B)(6) 2018 20:11:19 (B)(6). REPLACED C64; C270 ON LOGIC BOARD. (B)(6) 2018 20:13:03 (B)(6). VERIFIED SOLDER C64 AND C270 ON LOGIC BOARD. (B)(6) 2018 08:09:13 (B)(6). (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1027763	8015 ALARIS SYSTEM PC UNIT	PUMP, INFUSION	FRN	CAREFUSION SD	8015

Patients

Seq	Age	Sex	Outcome	Treatment
1