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Thesis
Manufacturing Improvements to the Centrifugal Pump Leading to an Increase in the Efficacy and Safety of the Pump During Clinical Use
Master of Science (M.S.), Drexel University
Jan 2011
DOI:
https://doi.org/10.17918/00007954
Abstract
With the development and refinement of the heart-lung machine, the repair of complicated congenital and acquired heart defects and disorders are very common procedures. During cardio-pulmonary bypass (CPB) surgery, a heart-lung machine is'used in conjunction with an extracorporeal blood flow circuit that maintains blood circulation to the patient's organs and tissues while the surgeon works on the heart in a safe and bloodless surgical field. One of the major components of this extracorporeal circuit is the arterial pump which essentially serves as the patient's heart in the heart-lung machine. This study addresses modifications made to improve the performance of such an arterial pump, the Centrifugal Pump produced by (Manufacturer Name Redacted). Since the first clinical use of CPB more than 50 years ago, numerous positive changes in the engineering and manufacturing of medical devices has made blood perfusion safer. Nevertheless, accidents still happen and there are a number of associated problems with the devices used during the surgery. One of the leading causes of patient mortality during CPB is device malfunction resulting in component change out. Components of the extracorporeal circuit are changed for a variety of reasons. Blood leakage is one of the primary causes. Particularly in the centrifugal arterial pump, blood leakage through the sealing surface created by the injection molded halar seal rotor and into the back chamber of the pump is significant reason to require component change out. In the medical device industry device malfunctions in the field are reported as complaints, and these complaints are then trended based upon complaints per million parts produced (CPM). Production and complaint data for the incidence of blood leaks in the (manufacturer ngme redacted) Centrifugal Pump were determined to be 41.09 CPM for FY2008 and 48.36 CPM for FY2009. It was hypothesized that improvements to the production process would increase the quality of the centrifugal pump, thereby resulting in a reduction in the incidence of failure (CPM) due to pump leaking in the field. These improvements included: (1) implementation of an automated seal rotor vision system to replace a subjective and inaccurate human inspection, (2) modifications to the application of a medical fluid aimed at reducing uneven wear of the seal rotor during clinical use, and (3) enhancements of the sensitivity of the centrifugal pump final leak tester to more accurately detect defects prior to device release to the field. Overall, it was the objective of this study to develop effective changes in these production procedures that would greatly reduce the likelihood of pump leaks in the field resulting in lower CPM. Since the implementation of these production improvements, over 72,000 Centrifugal Pumps have been produced, and from these pumps, not a single incidence of blood leaking has been reported which equates to a CPM of zero.
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Details
- Title
- Manufacturing Improvements to the Centrifugal Pump Leading to an Increase in the Efficacy and Safety of the Pump During Clinical Use
- Creators
- Brian T. Brooks
- Contributors
- Fred D. Allen Jr. (Advisor) - Drexel University, Drexel University (1970-)
- Awarding Institution
- Drexel University
- Degree Awarded
- Master of Science (M.S.)
- Publisher
- Drexel University; Philadelphia, Pennsylvania
- Number of pages
- xi, 102 pages
- Resource Type
- Thesis
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems (1997-2026); Drexel University
- Other Identifier
- 991021888903604721