FDA Adverse Event Malfunction Summary report: N

8110 ALARIS SYRINGE PUMP

MDR report key: 10559909 · Received September 21, 2020

Report

Report Number: 2016493-2020-10231
Event Type: Malfunction
Date Received: September 21, 2020
Report Date: January 31, 2018
Manufacturer: CAREFUSION SD
Product Code: FRN
UDI-DI: 10885403424267
PMA / PMN Number: K023264
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 TSC TROUBLESHOOTING PROCESS. 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 NOTIFICATION/S 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 NOT RETURNED FOR THE SERVICING WHICH NOT 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

CASE ID: (B)(4). CASE STATUS: OPEN. SUMMARY: 8120 13-1033-139 ERROR. CASE NOTES: PROBLEM DESCRIPTION - (B)(6) 2018 05:23:06 (B)(4). 8120 SN: (B)(4). 13-1033-139 ERROR. BIO MED FLASHED UNIT AND ERROR STILL OCCURRING. RECOMMEND TO CALIBRATE AND DO A PM ON UNIT TO SEE IF ERROR WILL CLEAR. LASTLY REPLACE LOGIC BD. GAVE PART NUMBER TO LOGIC BD. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1028554	8110 ALARIS SYRINGE PUMP	PUMP, INFUSION	FRN	CAREFUSION SD	8110		10885403424267

Patients

Seq	Age	Sex	Outcome	Treatment
1