Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
vTitan Corporation Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects willing to participate in the study. Subjects requiring intermittent or continuous infusion of fluid, medication or nutrients.
Exclusion criteria
Exclusion criteria: Subjects not willing to participate in the study. Subjects with a history of hypersensitivity to the medication being infused. Subjects with a history of hypersensitivity to the syringe pump components. Subjects having pain or swelling at infusion site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of Accuflow VE- Syringe pump To evaluate the performance of Accuflow VE-Syringe pumpTimepoint: the study will be 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Identifying previously unknown side-effects (related to the procedures or to the medical devices). 2.Monitoring the identified side-effects & contraindications. 3.Identifying and analyzing emergent risks 4.Ensuring the continued acceptability of the benefit-risk ratio. 5.Identifying possible systematic misuse or off-label use of the device. Possible misuse or off-label use of the device is given below: -Used by unskilled personnel -Not following safety instruction in user manual before using the device -Improper disposal of used batteries -Setting inappropriate volume of drug to be infused Timepoint: the study will be 3 months. | — |
Countries
India
Contacts
Public ContactDr Mathangi Krishnakumar
St. Johnâ??s Medical College Hospital,Bangalore
Outcome results
None listed