FDA Adverse Event Malfunction Summary report: N

ORGANOX METRA

MDR report key: 20150430 · Received September 5, 2024

Report

Report Number: 3011560054-2024-00075
Event Type: Malfunction
Date Received: September 5, 2024
Date of Event: August 8, 2024
Report Date: September 5, 2024
Manufacturer: ORGANOX LIMITED
Product Code: QQK
UDI-DI: 05060462240005
PMA / PMN Number: P200035
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

A SERVICE ENGINEER (SE) EVALUATED THE DEVICE AT THE CUSTOMER SITE. THE SE CLEANED THE INFERIOR VENA CAVA (IVC) FLOW SENSOR PRIOR TO TESTING. THE TESTS CONDUCTED SHOWED IVC FLOW RATES OF 2.8 LITERS PER MINUTE (L/MIN) IN PREPARATION MODE USING A SERVICE DISPOSABLE SET. THE SE ALSO VERIFIED THE CARD RACK AND INTERFACE BOARD (IFB) CONNECTORS AND RESEATED THE FLOW SENSOR CABLES PREVENTATIVELY. THE SE FINALLY TESTED THE DEVICE AGAIN AND BOTH FLOW SENSORS PERFORMED WITHOUT ISSUES. SYSTEM OPERATION WAS NORMAL.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE CUSTOMER REACHED OUT REGARDING MESSAGE CODES 250 (INFERIOR VENA CAVA FLOW SENSOR ERROR), 380 (LOW INFERIOR VENA CAVA FLOW), AND 390 (LOW HEPATIC ARTERY FLOW). THE CODES RANDOMLY PRESENTED ON THE GRAPHICAL USER INTERFACE (GUI) SCREEN AROUND SEVEN HOURS INTO THE PERFUSION. THE GUI SCREEN SHOWED NO INFERIOR VENA CAVA (IVC) OR ARTERIAL FLOW. IT WAS CONFIRMED THAT THE ARTERIAL AND IVC PRESSURES WERE WITHIN NORMAL RANGES AND THE ROTATIONS PER MINUTE (RPMS) READ AT 1600. THE CUSTOMER WAS GUIDED THROUGH TROUBLESHOOTING, BUT IT DID NOT RESOLVE THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1835550	ORGANOX METRA	NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR	QQK	ORGANOX LIMITED			05060462240005

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown