LETTERS TO THE EDITOR
Intraoperative Pulmonary Barotrauma During Ophthalmologic Surgery. Case report
Mrs. Editor,
The Right to Rebut (Law Number 2/99 of January 13, 1999) regarding the case report: Intraoperative Pulmonary Barotrauma During Ophthalmologic Surgery.
Public Information: the case reported by the Revista Brasileira de Anestesiologia happened at the Hospital Municipal Souza Aguiar - Rio de Janeiro, RJ, Brazil, on 02/21/2005 and was reported to the Quality Control and Technical Support of HB Hospitalar Ind. e Com. Ltda. (manufacturer of the equipment) on 02/25/2005, who initiated an analysis of the causes according to internal procedures and requirements regarding:
ANVISA Registration Number 10261120011
IEC, MC, and ELM-3678 Certification of 11/28/2001 (Electrical Safety and Compatibility)
ISO 9000 Certificate Number CE,SIQ-803
Good Practice of Manufacture Certificate (ANVISA) Number 179127/07-3
In which the results of Tests and Assays performed through Risk Analysis determined that the Anesthesia Machine Conquest 3000, Series 2369, and its accessories DID NOT present any non-conformities in the processes evaluated:
Project;
Safety;
Performance;
Assembly;
Ergonomics;
Fulfillment of statutory requirements; and
Quality Control
The positive results were presented to the person in charge of investigating the case at the above mentioned Hospital, Dr. Lília Portela, Chief of Anesthesiology, on March 17, 2005 through corroborating documents (Technical Reports) and procedure forms, according to each case.
According to the cause analysis, the situation occurred due to:
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The equipment mentioned was furnished, as requested by the client, with a smooth silicone tube, approximately 1.20-cm long and connectible intermediates only in the inspiratory branch of the ventilator to allow the assembly of a completely opened system using for this purpose a one-way valve, besides the tube.;
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As can be seen in the report, the tube is excessively long, and it is not the original tube provided for this application (to connect the ventilator to the circular filter);
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At the time, the client could not explain why the tubes were changed.
Preventive Actions:
Since this was probably an involuntary mistake made by the client, the engineering department of the HB Hospitalar was communicated immediately to take preventive actions to avoid similar occurrences in the future. It was determined:
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To use tracheal-type tubing, plain inside with reinforced rings outside to prevent kinking of the tube and interruption of the flow, regardless of the degree of curvature of the tubing (a series item in the manufacture);
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Specific orientation regarding the procedure of the circular filter operation (assembly and simulations), including a revision of the Manual of the Equipment with emphasis on this item; and
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The immediate substitution of the tubing of the client's equipment (who was satisfied with the actions taken and sent us a communication reporting the improvements).
Conclusion:
We should mention that HB Hospitalar Ind. e Com. Ltda has been in the market for 55 years, manufacturing and commercializing anesthesia equipment. It is a company with national and international certifications, according to the pertinent legislation, and has sold 220 units of the Conquest 3000 model without any non-conformities secondary to project flaws, performance, or safety. All those statements can be confirmed on consumer protection agencies in the ANVISA web site (www.anvisa.gov.br) or with its clients in Brazil and abroad.
The report mentioned above should have analyzed all facts, especially the conclusions of the manufacturer and the client, in view of the severity of the case, making public, besides the study of the case, the corrective actions taken that demonstrate concern with the most important parties, i.e., the patient and the client.
Thank you very much,
Harry Baukelmann
Director
HB Hospitalar Ind. e Com Ltda.
Muito obrigado,
Publication Dates
-
Publication in this collection
14 Oct 2011 -
Date of issue
Aug 2008
