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Solcotrans Orthopaedic Drainage Reinfusion System
Solco Basle
Summary: The Solcotrans Orthopaedic Drainage Reinfusion System is used for postoperative blood salvage in total joint arthroplasty. Key evidence shows reduced need for transfusions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K896857 ↗
Decision Date ?
April 5, 1990
Product Code ?
CAC
Device Class ?
Class 2
Evidence ?
0 studies
The Solcotrans Orthopaedic Drainage Reinfusion System was cleared by the FDA via the 510(k) pathway on April 5, 1990. It is manufactured by Solco Basle and classified as a Class 2 device.
What It Is
The Solcotrans Orthopaedic Drainage Reinfusion System is designed to collect and reinfuse autologous blood during the postoperative period in orthopaedic surgeries, particularly total joint arthroplasty. It aims to reduce the need for allogeneic blood transfusions.
FDA-Cleared Indications
- Collection and reinfusion of a patient's own shed blood during the postoperative period after orthopedic surgery.
- Use in postoperative blood salvage associated with total joint arthroplasty.
Clinical Applications
- Postoperative blood collection after total hip arthroplasty.
- Postoperative blood collection after total knee arthroplasty.
- Reinfusion of collected autologous blood when clinically indicated after orthopedic joint replacement.
- Use when reducing the need for allogeneic blood transfusion is desired.
Evidence Summary
The available literature includes two studies conducted in the early 1990s. These studies are prospective and randomized, involving a total of 83 patients, and focus on the efficacy of the Solcotrans system in reducing transfusion needs.
Reported Outcomes
Published studies report that the use of the Solcotrans system significantly reduces the need for postoperative blood transfusions in total joint arthroplasty. One study found that only 25% of patients required transfusions compared to 83% in the control group. In total knee arthroplasties, the need for transfusions was reduced to 11% in the study group.
Safety Profile
Reported complications include the general risks associated with postoperative blood salvage systems, although specific adverse events were not detailed in the provided studies. Overall, the system is considered safe when used as intended.
Evidence Limitations
The evidence is limited to two studies from the early 1990s, with small sample sizes and a narrow focus on total joint arthroplasty. Further research is needed to evaluate long-term outcomes and safety across diverse patient populations.
Practical Considerations
- This is a blood-collection and reinfusion system, not a replacement for surgical hemostasis, medication, or allogeneic transfusion when those treatments are clinically necessary.
- Use requires compatibility with the surgical drain, collection components, filters, and reinfusion setup specified in the device labeling.
- Collected blood should be handled, labeled, filtered, and reinfused according to the manufacturer's instructions and institutional blood-management policies.
- The system is intended for temporary postoperative use; it is not an implanted device and does not provide long-term therapy.
- MRI safety should not be assumed from the 510(k) clearance. The device and any attached components should be removed from the MRI environment unless current manufacturer labeling specifically identifies them as MR Safe or MR Conditional.
Frequently Asked Questions
What are the clinical indications for Solcotrans Orthopaedic Drainage Reinfusion System?
The device is indicated for use in postoperative blood salvage during total joint arthroplasty to reduce the need for allogeneic blood transfusions.
What outcomes have been reported in clinical studies?
Studies report a significant reduction in the need for postoperative blood transfusions, with only 25% of patients requiring transfusions compared to 83% in the control group.
What complications have been reported?
Reported complications include general risks associated with blood salvage systems, though specific adverse events were not detailed in the studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.