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.
[137556621]
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
[137556629]
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
| Report Number | 2015691-2019-00633 |
| MDR Report Key | 8364446 |
| Date Received | 2019-02-22 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2018-11-14 |
| Date Added to Maude | 2019-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VAMP OPTIMA SYSTEM |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2019-02-22 |
| Model Number | VOPTIMAL |
| Lot Number | 61734115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |