VENOUS HARDSHELL CARDIOTOMY RESERVOIR VHK 71000 70106.3805

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-07-28 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VHK 71000 70106.3805 manufactured by Maquet Cardiopulmonary Ag.

Event Text Entries

[20035613] On (b)(6) 2014 at the (b)(6) it was reported that there were large quantities of air being sucked into the venous line and the bo-02971 vhk 71000 venous reservoir from lot number 92119954 during pulsatile priming. The air was observed to be coming from the venous temperature probe on top of the venous inlet. The user tried to correct the problem by tightening the luer lock of the temperature probe but this did not resolve the issue. Eventually they removed the temperature venous probe and replaced it with a plug. Problem was solved: no air entry any more. Bypass surgery was started without further problem. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[20428656] (b)(4). The sample was not returned to the manufacturer and hence no evaluation was performed. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010762-2015-00496
MDR Report Key4945017
Report Source01,05,06
Date Received2015-07-28
Date of Report2014-12-16
Date of Event2014-12-16
Date Facility Aware2014-12-16
Report Date2014-12-16
Date Reported to Mfgr2014-12-16
Date Mfgr Received2014-12-16
Date Added to Maude2015-07-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTINA EVANCHO
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer Phone9737097265
Manufacturer G1MAQUET CARDIOPULMONARY AG
Manufacturer StreetKEHLER STRASSE 31
Manufacturer CityRASTATT, 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENOUS HARDSHELL CARDIOTOMY RESERVOIR
Generic NameRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
Product CodeDTN
Date Received2015-07-28
Model NumberVHK 71000
Catalog Number70106.3805
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMONARY AG
Manufacturer AddressKEHLER STRASSE 31 RASTATT, 76437 GM 76437


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-28

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