FDA Adverse Event Malfunction Summary report: N

8100 ALARIS PUMP MODULE

MDR report key: 11018286 · Received December 16, 2020

Report

Report Number: 2016493-2020-68734
Event Type: Malfunction
Date Received: December 16, 2020
Report Date: July 24, 2019
Manufacturer: CAREFUSION SD
Product Code: FRN
UDI-DI: 10885403810015
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.

Description of Event or Problem · 1

BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). CASE DESCRIPTION: TECH. CALLED IN FOR HELP ON ERROR CODE 200-5040 ON 8100 UNIT SERIAL # (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8100. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: CONFIRM TO TECH. ERROR CODE 200-4050 HAS TO DO WITH PUMP SOFTWARE VERSION IS NOT COMPATIBLE WITH SOFTWARE FLASHED INTO PC UNIT NEEDS TO REFLASH SOFTWARE BUT IF FLASH FAILS TRY AGIAN IF CONTINURE TO FAIL YOU WILL NEED TO REPLACE LOGIC BOARD. CUSTOMER THANK ME FOR MY ASSIST. REF: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1483026	8100 ALARIS PUMP MODULE	PUMP, INFUSION	FRN	CAREFUSION SD	8100		10885403810015

Patients

Seq	Age	Sex	Outcome	Treatment
1