FDA Adverse Event Malfunction Summary report: N

8110 ALARIS SYRINGE PUMP

MDR report key: 11121609 · Received January 5, 2021

Report

Report Number: 2016493-2020-87396
Event Type: Malfunction
Date Received: January 5, 2021
Report Date: October 28, 2019
Manufacturer: CAREFUSION SD
Product Code: FRN
PMA / PMN Number: K133532
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. 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 RETURNED FOR SERVICING WHICH 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

CASE #: 00883353 CASE SUBJECT: NPI 8110 ERROR 354.6770 ACCOUNT NAME: ST VINCENT HOSPITAL & HEALTH SERVICES ACCOUNT #: 1780200 ASSET NAME: 8110 SYRINGE MODULE V8.5.6 R ASSET LOCATION: CONTACT: DARRICK TURNER CONTACT EMAIL: CONTACT PHONE: (317) 376 0394 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: DARRICK HAD ERROR 354.6770 ON SYRINGE8110 SN 13994540 FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8110 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I RECOMMENDED DARRICK TO REPLACE PRESSURE SENSOR BOARD. DARRICK WILL REPLACE PRESSURE SENSOR BOARD. IF HE STILL HAVE PROBLEM, HE WILL CALL ME BACK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17792	8110 ALARIS SYRINGE PUMP	PUMP, INFUSION	FRN	CAREFUSION SD	8110

Patients

Seq	Age	Sex	Outcome	Treatment
1