VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160 manufactured by Edwards Lifesciences Dr.

Event Text Entries

[114677428] The device was not returned for evaluation; it was discarded at the hospital. Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event. No corrective actions will be taken at this time. Lot number was not provided; therefore review of the manufacturing records could not be completed. It is common clinical practice to inspect all products before usage. These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use. If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications. It is unknown whether user or procedural factors played a role in this event. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10


[114677429] It was reported that during use, the pressure tubing detached which caused an arterial hemorrhage and approximately 200 ml of blood loss. There was no need for a transfusion. No other patient complications reported. The device was discarded at the hospital. Patient demographics were unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2018-02849
MDR Report Key7691945
Date Received2018-07-16
Date of Report2018-06-26
Date of Event2018-06-22
Date Mfgr Received2018-06-26
Date Added to Maude2018-07-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SAMANTHA EVELEIGH
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492503939
Manufacturer G1EDWARDS LIFESCIENCES DR
Manufacturer StreetPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR
Generic NameKIT, SAMPLING, ARTERIAL BLOOD
Product CodeCBT
Date Received2018-07-16
Model Number48VMP160
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES DR
Manufacturer AddressPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.