FDA Adverse Event Malfunction Summary report: N

CADD

MDR report key: 13409351 · Received February 1, 2022

Report

Report Number: 3012307300-2022-02237
Event Type: Malfunction
Date Received: February 1, 2022
Report Date: February 1, 2022
Manufacturer: ST PAUL
Product Code: FRN
UDI-DI: 10610586019647
PMA / PMN Number: K982836
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE SERIAL NUMBERS FROM THE PUMPS THAT CUSTOMER HAVE HAD TROUBLE WITH ARE (B)(4). THE LOT NUMBERS AND EXPIRATION DATES ON THE CADD CASSETTES WERE PRODUCT NUMBER 21-7302-24, LOT 4095686, EXPIRATION DATE (B)(6) 2026 AND PRODUCT NUMBER 21-7302-24, LOT 4122832, EXPIRATION DATE (B)(6) 2026.

Description of Event or Problem · 0

INFORMATION WAS RECEIVED REGARDING A CADD LEGACY PLUS PUMP. IT WAS REPORTED THAT THE DEVICE HAS BEEN ALARMING BEFORE THE MEDICATION IS COMPLETELY INFUSED. THE ERROR ON THE PUMP WAS "NO DISPOSABLE, PUMP WON'T RUN." THIS OCCURRED ON TWO PUMPS IN THE PAST WEEK. ONE CASSETTE HAD APPROXIMATELY 100ML REMAINING WHEN IT ALARMED. THE OTHER HAD ABOUT 5ML REMAINING. THEY CONTACTED SIMS DELTEC, INC., AND A REPRESENTATIVE STATED THAT THERE HAD BEEN A CHANGE IN THE PRODUCT INVOLVED A FLOWTOP VALVE. ADDITIONAL INFORMATION REPORTED THAT THERE WERE FOUR TOTAL EVENTS, ALL OF WHICH HAD PATIENT INVOLVED. CUSTOMER DID NOT PROVIDE INFORMATION AS TO WHICH PUMP AND CASSETTE WERE USED WITH EACH PATIENT. ONE PATIENT CAME IN EARLY AND THE NURSE WAS ABLE TO GET THE PUMP RUNNING AGAIN SO PATIENT COULD FINISH INFUSION. THERE WAS A SLIGHT EXTENDED INFUSION TIME, OTHERWISE, NO INJURIES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1310341	CADD	INFUSION PUMP	FRN	ST PAUL	21-6500-51		10610586019647

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female