FDA.reportPublic FDA data

MAUDE MDR 9785200

MDR report key
9785200
Report number
2916596-2020-01177
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-04
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
MR. BOB FRYC
Address
6035 STONERIDGE DRIVE PLEASANTON CA 94588 US
Phone
781-781-7818
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CENTRIMAG MOTOR, OUSPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPETHORATEC SWITZERLAND GMBHKFM201-100026908093R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0401. H; 2. R

Event Narratives#

N

Patient 1

NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER?S INVESTIGATION IS COMPLETED.

D

Patient 1

IT WAS REPORTED THAT A NEWBORN PATIENT WAS IMPLANTED ON (B)(6) 2020 AT REMOTE CENTER WITH VENOUS-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND TRANSFERRED TO GENERAL UNIVERSITY HOSPITAL (VFN) HOSPITAL. SUPPORTING THERAPY INCLUDING THROMBO-CONCENTRATES AND FIBRINOGEN ADMINISTERED. THE CENTRIMAG (CMAG) SYSTEM WAS STABLE ON 2900 RPM WITH FLOW 290 - 300 MLS/MIN. ON (B)(6) 2020, THE CLINICAL TEAM REPORTED SUDDEN DECREASE OF GENERATED FLOW UP TO 0 MLS/MIN WITH STABLE RPM AND A FLOW BELOW MINIMUM ALARM; THE RETURN LINE WAS CLAMPED AND THEY TRIED TO RESTART FLOW BY DECREASING AND INCREASING RPM WITH AN OPEN RETURN LINE. THERE WAS NO IMPROVEMENT SO THE CMAG CIRCUIT WAS TRANSFERRED TO A BACKUP CENTRIMAG CONSOLE AND MOTOR, BUT THERE WAS NO NOTED IMPROVEMENT. THE NEW CMAG CIRCUIT WAS EXCHANGED WITH THE REMOVAL OF A SMALL THROMBI FROM THE ARTERIAL CANNULAE (RETURN). SUPPORT THERAPY WAS CONTINUED, INCLUDING THROMBO-CONCENTRATES AND FIBRINOGEN ADMINISTRATION. ON (B)(6) 2020, THE CLINICAL TEAM REPORTED SUDDEN DECREASE OF GENERATED FLOW UP TO 0 MLS/MIN WITH STABLE RPM AND A FLOW BELOW MINIMUM ALARM; THE RETURN LINE WAS CLAMPED AND THEY TRIED TO RESTART FLOW BY DECREASING AND INCREASING RPM WITH AN OPEN RETURN LINE. THERE WAS NO IMPROVEMENT, SO A NEW MAQUET PLS ECMO CIRCUIT WAS EXCHANGED WITH THE REMOVAL OF A SMALL THROMBI FROM THE ARTERIAL CANNULAE (RETURN). THE PATIENT CONTINUED TO RECEIVE THERAPY WITHOUT ANY EVENT AND ELECTIVE DECOMMISSIONING OF ECMO ON (B)(6) 2020. BOTH THE INITIAL CMAG SYSTEM AND BACKUP CMAG SYSTEM HAD TO BE EXCHANGED DUE TO LOW FLOW. THIS EVENT IS ALSO REPORTED UNDER MFR #2916596-2020-01175, MFR# 2916596-2020-01176, MFR#2916596-2020-01174.