FDA Adverse Event Malfunction Summary report: N

BODYGUARD 121 INFUSION PUMP

MDR report key: 9891225 · Received March 27, 2020

Report

Report Number: 3006967710-2020-00004
Event Type: Malfunction
Date Received: March 27, 2020
Date of Event: March 6, 2020
Report Date: March 6, 2020
Manufacturer: CME AMERICA LLC
Product Code: FRN
PMA / PMN Number: K042696
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

CME AMERICA'S BODYGUARD 121 INFUSION PUMP IS CLASSIFIED AS FRN BY THE FDA, WHICH IS NOT FOR LIFE-SUSTAINING MEDICATIONS. CME AMERICA'S INSTRUCTIONS FOR USE CLEARLY STATE, "THE BODYGUARD 121 INFUSION PUMP SYSTEM SHOULD NOT BE USED TO INFUSE LIFE SUSTAINING MEDICATIONS WHOSE STOPPAGE OR INTERRUPTION COULD CAUSE SERIOUS INJURY OR DEATH." THE CUSTOMER USED THE DEVICE OFF LABEL.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THE DEVICES ARE EXPERIENCING RESTART PUMP MESSAGES. THE DELAY IN THERAPY WAS ABOUT TWO MINUTES TO GET THE DEVICES RESTARTED AND CONTINUE THERAPY. THERE WAS NO HARM TO THE PATIENT. A CME AMERICA INTERNAL CLINICIAN MARKED THE MEDICATION USED AS FOR CRITICAL USE. ACCORDING TO THE BODYGUARD 121 OPERATOR'S MANUAL, THE USE OF NITROGLYCERIN IS AN OFF LABEL USE OF THE DEVICE. SEE CHAPTER 3 UNDER GENERAL WARNINGS: "THE BODYGUARD 121 INFUSION PUMP SYSTEM SHOULD NOT BE USED TO INFUSE BLOOD, BLOOD PRODUCTS, OR LIFE-SUSTAINING MEDICATIONS WHOSE STOPPAGE OR INTERRUPTION COULD CAUSE SERIOUS INJURY OR DEATH." THE CUSTOMER USED THE DEVICE OFF LABEL. THE DEVICE HAS NOT YET BEEN EVALUATED AND THE INVESTIGATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
354984	BODYGUARD 121 INFUSION PUMP	BG 121 PUMP	FRN	CME AMERICA LLC	100-105TSA

Patients

Seq	Age	Sex	Outcome	Treatment
1