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Infusion system made with PC/ABS compound

to alcohol (for cleaning), and an aesthetically pleasing appearance. Another motivating factor for Tandem's choosing RTP's compound was the material's ability to be formed into large, complex shapes without distortion. The pump itself features a large, flat, stainless-steel spring that operates similarly to those found in mechanical watches: as the housing is opened, the spring retracts to its original position. The stored force then dispenses up to four intravenous solutions from the bag. If the system is dropped, RTP's compound offers protection with unnotched Izod impact strength at 3.18 mm of 801 J/m. The compound's flexural strength is 26,000 psi; its tensile strength is 18,000 psi.

The 411 on CAPA

Originally Published MX November/December 2001

GOVERNMENTAL & LEGAL AFFAIRS

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Managing for Quality

A good CAPA management system should be able to pull together a great deal of information from a variety of areas. Potential sources of data about product-quality issues include the following.3

  • Acceptance activity records relating to component, in-process, and finished-device testing.
  • Complaints.
  • Medical device reports (MDRs) and vigilance reports.
  • FDA 483s and warning letters.
  • Reports of system, process, or product nonconformities.
  • Process-monitoring data such as statistical control charts, trends, and run charts.
  • Calibration and maintenance records.
  • Scrap, rework, and "use-as-is" records.
  • Clinical adverse events.
  • Internal, external, supplier, and third-party audits.
  • Returned-product analysis.
  • Installation and repair reports.
  • Spare parts usage.
  • Customer and technical service requests.
  • Field service and warranty reports.
  • Customer feedback.
  • Historical records from previous corrections.
  • Previous corrective and preventive actions.
  • Lawsuits and