VAMP UNKNOWN VAMPUNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-22 for VAMP UNKNOWN VAMPUNKNOWN manufactured by Edwards Lifesciences Dr.

Event Text Entries

[108992727] The device was not returned for evaluation as 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. It is not known if some user or procedural factors may 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. Invasive procedures involve some form of patient risk. Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the potential complications. An incorrect flow rate on a dpt can result in significant unintended fluid delivery which can pose a risk to the patient. As previously stated, it is unknown at this time whether an adult or pediatric dpt was being used and if a pediatric dpt, whether the system was on a pump. Use of a pump on a pediatric dpt system can prevent incorrect flow rate from occurring. An edwards representative met with a clinical nurse specialist and nurse educator after the event and an in-servicing was performed. 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


[108992728] It was reported 500mls of normal saline was infused into a (b)(6) patient when using the vamp jr and disposable pressure transducer (dpt) system. The fluid was infused over a 4-hour time frame. The dpt system was on a pressure bag set-up using 300mmhg. It is unknown at this time whether an adult or pediatric dpt was being used and if a pediatric dpt, whether the system was on a pump. There was no patient injury reported. The device was discarded at the hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2018-01948
MDR Report Key7535480
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-05-22
Date of Report2018-04-29
Date of Event2018-04-29
Date Mfgr Received2018-04-29
Date Added to Maude2018-05-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS LYNN SELAWSKI
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9497564386
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 Report3

Device Details

Brand NameVAMP UNKNOWN
Generic NameKIT, SAMPLING, ARTERIAL BLOOD
Product CodeCBT
Date Received2018-05-22
Model NumberVAMPUNKNOWN
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 2018-05-22

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