FDA.reportPublic FDA data

MAUDE MDR 9803141

MDR report key
9803141
Report number
3010617000-2020-00234
Event key
0
Event type
3
Date of event
2020-02-12
Date received
2020-03-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS KIMTHOA NGUYEN
Address
2000 RINGWOOD AVE, SAN JOSE, CA US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZOLL IVTM QUATTRO CATHETERCENTRAL VENOUS CATHETERZOLL CIRCULATIONNCXIC-4593AE8700-0783-0199639Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-060

Event Narratives#

N

Patient 1

THE REPORTED COMPLAINT OF A LEAKING QUATTRO CATHETER WAS CONFIRMED DURING FUNCTIONAL TESTING. A LEAK ON THE CATHETER'S SHAFT WAS OBSERVED. THE INVESTIGATION FINDINGS REVEALED THAT THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A SMALL SHARP CUT AT 6 CM AWAY FROM THE DISTAL END OF THE MANIFOLD WHICH IS A CHARACTERISTIC OF A CUTTING INSTRUMENT, LIKELY CAUSED BY USER ERROR. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE AND IMMEDIATELY A LEAK ON THE CATHETER'S SHAFT WAS OBSERVED. THUS, CONFIRMING THE REPORTED COMPLAINT. ADDITIONALLY, THE RETURNED QUATTRO CATHETER WAS VISUALLY INSPECTED UNDER A MICROSCOPE AND A SMALL SHARP CUT AT 6 CM AWAY FROM THE DISTAL END OF THE MANIFOLD WAS OBSERVED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR QUATTRO CATHETER WITH LOT NUMBER 99639.

D

Patient 1

THE CUSTOMER REPORTED THAT ON THE SECOND DAY OF IVTM THERAPY, DURING THE REWARMING PHASE, THE SALINE BAG WAS NOTICED EMPTY AND THE THERMOGARD CONSOLE GENERATED AN AIR TRAP ALARM. THERE WERE NO SIGNS OF FLUID ON THE FLOOR OR NEAR THE PATIENT'S BED. THERE WERE NO ISSUES REPORTED FOR THE START-UP KIT (SUK). THE CATHETER LEAK WAS SUSPECTED. THE CATHETER WAS REMOVED AND AN ALTERNATIVE METHOD WAS USED TO COMPLETE PATIENT TREATMENT. NO DEVICE MALFUNCTION WAS REPORTED FOR THE CONSOLE. NO CONSEQUENCES OR IMPACT TO PATIENT.