FDA Adverse Event Malfunction Summary report: N

CADD MEDICATION CASSETTES

MDR report key: 14501265 · Received May 25, 2022

Report

Report Number: 3012307300-2022-09642
Event Type: Malfunction
Date Received: May 25, 2022
Date of Event: March 1, 2022
Report Date: May 25, 2022
Manufacturer: ST PAUL
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED, OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE CASSETTE WAS MALFUNCTIONING. THIS WAS THE THIRD CASSETTE FROM THIS LOT NUMBER 4220003 THAT IS DEFECTIVE. PATIENT'S PUMP ALARMED; SHE SWITCHED TO BACKUP PUMP. THE ALARM CONTINUED SHE MADE A NEW CASSETTE, AND THE PUMP STOPPED ALARMING. NO PATIENT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
285052	CADD MEDICATION CASSETTES	SET, ADMINISTRATION, INTRAVASCULAR	FPA	ST PAUL		4220003

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown