一級召修 Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit

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Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit

 
Pump 3860, 3860+ with SpO2  

"優耐美"輸液系統 百世生醫科技有限公司  ＊＊＊ 衛署醫器輸字第018450號 ＊＊＊ (國內僅引進3850，QSD上未見3860登記)

"優耐美"輸液系統及其配件 輸液系統 百世生醫科技有限公司  ＊＊＊ 衛署醫器輸字第020272號 ＊＊＊  (國內僅引進1055, 1056, 1057, 1119,QSD上未見1145登記)

Recall Class: Class I

Date Recall Initiated: July 1, 2013
Product: MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit. (3860配備1145DERS系統)
The MRidium 1145 Dose Reduction System (DERS) drug library kit is an accessory intended for use with the MRidium 3860+ Infusion Pump System.

This recall does not affect the following products: (未配備1145DERS都不受影響)

• MRidium™ 3860+ Infusion Pump used without the DERS (Part No. 1145) Kit
• MRidium™ 3861 Infusion Pump Channel B accessory.
• MRidium™ 3865 Infusion Pump Remote Display accessory.
• None of the MRidium™ 3850 Infusion Pump products (models 3850, 3851, or 3855).

Part number 1145 Lots: 4501,4510, 4538, 4587, 4596, 4675, 4690, 4705, 4738, 4748, 4960, 4970, 5001, 5065, 5104, 6164, 5221, 5240, 5349, 5361, 5517, 5737, 5764, 5881, 6006, 6151, 6170, 6180, 6252, 6470, 6583, 6806, 6881, 6984, and 7213.
These products were manufactured from Oct. 1, 2011 through June 27, 2013 and distributed from Oct. 6, 2011 through June 28, 2013.
Use: The MRidium 3860+ Infusion pumps are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with fluids and/or medications into the vein (intravenous) or through the artery (intra-arterial) before, during or after Magnetic Resonance Imagining (MRI) scans.

Recalling Firm:
Iradimed Corporation
7457 Aloma Ave., Suite 201
Winter Park, Florida 32792-9172

Reason for Recall: The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This is due to a specific key sequence when the override feature of the DERS drug limits is activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. This can cause serious adverse health consequences, including death.

Public Contact: Iradimed Customer Service (toll-free) at 1-866-677-8022 or 407-677-8022 ext. 100 or by e-mail at recallsupport@iradimed.com.

FDA District: Florida District Office

FDA Comments:
Iradimed Corporation notified its customers by phone and on July 1, 2013 they sent an URGENT MEDICAL DEVICE RECALL NOTICE^1 2 to all customers. The notice described the product, problem and actions to be taken.

The customers were instructed to identify the MRidium 3860+ Infusion Pumps which have the 1145 DERS Library card (AM05) installed. If these are not installed, no further action is required at this time. However, if the DERS Library card is installed, remove the 1145 DERS Library Card from the 3860 Pump using the instructions provided in the URGENT MEDICAL DEVICE RECALL NOTICE.

The product will be repaired (reconditioned) by installing a software upgrade that corrects this problem. The updated software (version 3.5.1) can be seen during the 3860+ Pump's power on cycle.

Users who have any questions following these instructions should contact Iradimed Customer Service toll-free at 1-866-677-8022 or 407-677-8022 ext. 100 or by e-mail at recallsupport@iradimed.com.

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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program³ either online, by regular mail or by FAX.