DP-38 BIO-PROBE DISPOSABLE INSERT 95133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 1998-07-15 for DP-38 BIO-PROBE DISPOSABLE INSERT 95133 manufactured by Medtronic Bio-medicus, Inc..

Event Text Entries

[121734] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124837-1998-00010
MDR Report Key178080
Report Source01,05,06,07,08
Date Received1998-07-15
Date of Report1998-07-14
Date of Event1998-06-15
Date Facility Aware1998-06-17
Report Date1998-07-14
Date Mfgr Received1998-06-22
Date Added to Maude1998-07-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameDP-38 BIO-PROBE DISPOSABLE INSERT
Generic NamePROBE, BLOOD FLOW, EXTRACORPOREAL
Product CodeDPT
Date Received1998-07-15
Returned To Mfg1998-06-22
Model NumberDP-38
Catalog Number95133
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key173162
ManufacturerMEDTRONIC BIO-MEDICUS, INC.
Manufacturer Address9600 WEST 76TH ST. EDEN PRAIRIE MN 55344 US
Baseline Brand NameBIO-PROBE DISPOSABLE INSERT
Baseline Generic NameEXTRAVASCULAR BLOOD FLOW PROBE
Baseline Model NoDP-38
Baseline Catalog No95133
Baseline IDBIO-PROBE FLOW
Baseline Device FamilyBIO-PROBE
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK830858
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-07-15

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