VAMP OPTIMA SYSTEM VOPTIMAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for VAMP OPTIMA SYSTEM VOPTIMAL manufactured by Edwards Lifesciences Dr.

Event Text Entries

[137529203] An investigation into the event concluded that per the product step-guide, clinicians were instructed to have the lass sample site in the monitoring position while drawing a clearing volume into the vamp reservoir. With this incorrect stopcock positioning, a small amount of saline remained in the lass sample site. Therefore, when the clinician performed a 1-2cc blood draw from the sample site, the blood sample was diluted with saline. This blood draw was used to obtain blood glucose readings. The clinician stated that once the glucose reading was obtained it was immediately evident that the sample had been diluted. Although there was a potential for inappropriate treatment to be provided, none occurred. Of note, the ifu is silent on this procedural step. A corrective action plan is currently being developed. A review of the manufacturing records indicated that the product met specifications upon release. Udi# (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[137529204] It was reported that glucose readings were diluted during use of a vamp optima with lass sample site system. No patient complications were reported. Patient demographics were unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2019-00634
MDR Report Key8364449
Date Received2019-02-22
Date of Report2019-01-25
Date of Event2018-12-11
Date Mfgr Received2019-01-25
Device Manufacturer Date2018-11-14
Date Added to Maude2019-02-22
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 ContactMRS LYNN SELAWSKI
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
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 OPTIMA SYSTEM
Generic NameKIT, SAMPLING, ARTERIAL BLOOD
Product CodeCBT
Date Received2019-02-22
Model NumberVOPTIMAL
Lot Number61734115
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 2019-02-22

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