FDA Adverse Event Malfunction Summary report: N

ALARIS PUMP MODULE

MDR report key: 11171847 · Received January 14, 2021

Report

Report Number: 2016493-2021-09790
Event Type: Malfunction
Date Received: January 14, 2021
Report Date: January 5, 2021
Manufacturer: CAREFUSION SD
Product Code: FRN
PMA / PMN Number: K133532
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 0

TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF: 8100 ERROR CODE 13-1033-149. TECHNICAL SUPPORT - LOGIC BOARD: INFORMED MOST LIKELY DUE TO THE LOGIC BOARD. HOWEVER RECOMMENDED REFLASHING FIRMWARE. WALKED CUSTOMER THROUGH FLASHING. RECOMMENDED PERFORMING PM. IF ERROR CODE PERSIST, SEND IN FOR A LEVEL TWO REPAIR. A SERIAL NUMBER WAS NOT PROVIDED THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED. BASED ON THE FINDINGS, TECHNICAL SUPPORT DETERMINED THAT THE PROXIMATE CAUSE OF THE REPORTED ISSUE. TECH SUPPORT - INFORMED MOST LIKELY DUE TO THE LOGIC BOARD. HOWEVER RECOMMENDED RE-FLASHING FIRMWARE. THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. H3 OTHER TEXT : NO PRODUCT RETURNED.

Description of Event or Problem · 0

THE CUSTOMER REPORTED ERROR CODE 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative · 1

NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED ERROR CODE 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
69949	ALARIS PUMP MODULE	PUMP, INFUSION	FRN	CAREFUSION SD	8100

Patients

Seq	Age	Sex	Outcome	Treatment
1