ADULT BIO-PROBE FLOW PROBE 3/8" CBDP-38 CB2980

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,07 report with the FDA on 1998-04-29 for ADULT BIO-PROBE FLOW PROBE 3/8" CBDP-38 CB2980 manufactured by Medtronic Cardiopulmonary.

Event Text Entries

[85166] The report indicated that following 45 hours of extra corporeal membrane oxygenator support, leakage was observed. The flow probe was changed out. Based upon condition of the returned device co was unable to complete the failure investigation and determine the exact failure mode.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2022036-1998-00018
MDR Report Key165308
Report Source01,04,05,07
Date Received1998-04-29
Date of Report1998-04-29
Date of Event1998-03-29
Date Mfgr Received1998-03-30
Device Manufacturer Date1997-06-01
Date Added to Maude1998-05-04
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 Location0
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameADULT BIO-PROBE FLOW PROBE 3/8"
Generic NameFLOW PROBE
Product CodeDPT
Date Received1998-04-29
Returned To Mfg1998-04-16
Model NumberCBDP-38
Catalog NumberCB2980
Lot Number9706000872
ID NumberN/A
Device Expiration Date1999-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key160891
ManufacturerMEDTRONIC CARDIOPULMONARY
Manufacturer Address4633 EAST LA PALMA AVE. ANAHEIM CA 92807 US
Baseline Brand NameADULT BIO-PROBE FLOW PROBE 3/8"
Baseline Generic NameFLOW PROBE
Baseline Model NoCBDP-38
Baseline Catalog NoCB2980
Baseline IDNA
Baseline Device FamilyFLOW PROBE
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK891687
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1998-04-29

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