BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE 70104.8887

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 report with the FDA on 2014-08-07 for BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE 70104.8887 manufactured by Maquet Cardiopulmonary Ag.

Event Text Entries

[4999770] It was reported that during use on a pt. Accumulation of air was observed on the lower side of the de-airing cock. Air accumulation was observed soon after manipulating the de-airing cock. The customer suspects the failure is due to the back-flow valve and/ or the product housing. Device use was continued with no reported pt effect. Blood flow rate: 3. 6l/min. Aspiration pressure: -56mmhg". (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12484483] (b)(4). A health hazard eval was initiated and the hazard has been defined. Based on new info available (b)(4) 2014, a re-assessment of the reporting obligation was performed and this event was determined to be reportable. Maquet cardiopulmonary is aware of similar complaints and an internal process (b)(4) was initiated to determine the root- cause and implement the appropriate corrective action. A supplemental medwatch will be submitted when add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010762-2014-00295
MDR Report Key4219065
Report Source01,05,06,07
Date Received2014-08-07
Date of Report2014-08-01
Date of Event2001-07-15
Date Facility Aware2014-08-06
Report Date2014-08-07
Date Mfgr Received2014-08-01
Device Manufacturer Date2013-12-01
Date Added to Maude2014-11-06
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 ContactJANICE PEVIDE
Manufacturer Street45 BARBOUR POND DR
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer Phone9737097753
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 NameBO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE
Generic NameVBT (VENOUS BUBBLE TRAP)
Product CodeDTP
Date Received2014-08-07
Returned To Mfg2014-07-28
Catalog Number70104.8887
Lot Number92125382
Device Expiration Date2015-12-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age8 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMONARY AG
Manufacturer AddressRASTATT GM


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-07

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