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MAUDE MDR 178080

MDR report key
178080
Report number
2124837-1998-00010
Event key
0
Event type
3
Date of event
1998-06-15
Date received
1998-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DP-38 BIO-PROBE DISPOSABLE INSERTPROBE, BLOOD FLOW, EXTRACORPOREALMEDTRONIC BIO-MEDICUS, INC.DPTDP-3895133UNKK830858NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-07-1501. O

Event Narratives#

D

Patient 1

HOSPITAL REPORTED THAT DURING CARIOPULMONARY SUPPORT, BLOOD LEAKED FROM THE DP-38 BIO-PROBE DISPOSABLE INSERT. THE DEVICE WAS REMOVED FROM THE CIRCUIT AND REPLACED WITH ANOTHER BIO-PROBE INSERT. CASE WAS COMPLETED WITH NO EFFECT TO THE PATIENT.