FDA Adverse Event Malfunction Summary report: N

MEDSYTEM III INFUSION PUMP

MDR report key: 11300075 · Received February 9, 2021

Report

Report Number: 2016493-2021-25025
Event Type: Malfunction
Date Received: February 9, 2021
Report Date: August 15, 2018
Manufacturer: CAREFUSION SD
Product Code: FRN
UDI-DI: 10885403928659
PMA / PMN Number: K933545
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 SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE 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 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

08/15/2018 04:13:49 ZENITH SOMANI (ZSOMANI) PHONE 800-387-8309 1 THERE WAS NO PATIENT INVOLVEMENT 08/30/2018 05:30:42 SENTHURAN SIVASAMBO (SSIVASAM) 1ZR236E61445423724

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
197921	MEDSYTEM III INFUSION PUMP	PUMP, INFUSION	FRN	CAREFUSION SD	2865		10885403928659

Patients

Seq	Age	Sex	Outcome	Treatment
1