clear HLD 消毒式清洗機 塑膠蓋板破裂

(http://bme.freebbs.tw 醫學工程論壇同步發表)

名稱: Clear HLD 消毒式清洗機

故障情形：蓋板破裂

故障原因：塑膠蓋板破裂

這台清洗機是利用巴斯德消毒原理來清洗呼吸器管路，機械構造基本上就是類似一台洗衣機，把管路環繞在筒內，再用蓋板壓住。

   

蓋板也因使用頻繁，塑膠板破裂，但因為外繞的不鏽鋼圈仍完好，所以考慮找替代的東西換上去，不然原廠的報價也是很高的，連代理商也都覺得直接找不鏽鋼片放上去就可以了。

  

仔細看一下構造，只要照原末本的尺寸折壓薄不鏽鋼片，可以減重量，但是要滾邊，才不會造成割手情形，這種大概都是得純手工吧，所以沒什麼人願意接，最後找到專門做金桶店(燒紙錢用的)，他們有在用薄不鏽鋼片做水桶及相關器具，當下老板也覺得有點好玩，就答應了，成品如下，又解決了一件，不過還有5個要做，不知道老板肯不肯再做

   

一級召修 Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

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Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

Recall Class: Class I

Date Recall Initiated: August 21, 2013

Products: Siemens Material Number / Part Number

• Synergies plus Negative Urine Combo 1- 10444745 / B1025-106
• Synergies plus Negative Combo 2 - 10444747 / B1025-108
• Synergies plus Negative Breakpoint Combo 7 - 10444748 / B1025-109 
  "西門子"革蘭氏陰性菌協同折點複合檢驗組七型 ＊＊＊ 衛署醫器輸字第023651號 ＊＊＊
• Synergies plus Negative Urine Combo 2 - 10444749 / B1025-112
  "西門子"革蘭氏陰性尿液協同快速複合板 2 型  ＊＊＊ 衛署醫器輸字第019938號 ＊＊＊
• Synergies plus Negative Urine Combo 5 - 10483101 / B1025-115
  "西門子"革蘭氏陰性尿液協同複合檢驗組五型  ＊＊＊ 衛署醫器輸字第023654號 ＊＊＊

This recall covers 78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.

Use: MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels are used for determining antimicrobial susceptibility and/or identification for gram-negative bacteria.

Recalling Firm:Siemens Healthcare Diagnostics, Inc.
2040 Enterprise Blvd
West Sacramento, CA 95691-3427

Reason for Recall: MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.

使用的MicroScan的WalkAway系統配合 MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels 會出現不正確的中間亞胺培南(imipenem )和美羅培南(meropenem )藥敏試驗結果。這問題可能會導致不適當的抗生素治療或延遲啟動適當的治療時機。

Public Contact:Siemens Healthcare Diagnostics, Inc. at 1-800-677-7226 Option 1 (USA/Canada)

FDA District: San Francisco

FDA Comments:Siemens sent an Urgent Field Safety Notice dated August 21, 2013, to all affected customers. The letter identified the defective products, problem and actions to be taken. The letter instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing.

Customers are further asked to confirm receipt of the Safety Notice by returning a Field Correction Effectiveness Check Sheet by fax to (302) 631-8467. In addition, an Important Product Information notice will be added to products manufactured in future kits.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.