《胰岛素泵被带进核磁共振(mri)室后的注意事项》由会员分享，可在线阅读，更多相关《胰岛素泵被带进核磁共振(mri)室后的注意事项（5页珍藏版）》请在金锄头文库上搜索。
1、IfIf YouveYouve ExposedExposed YourYour ParadigmParadigm PumpPump toto anan MRI,MRI, YouYou NeedNeed toto ReadRead ThisThisLindaLinda vonvon WartburgWartburg Jul 20, 2007 If your Paradigm pump has been notnot been exposed to powerful magnetic fields, such as those found near MRI machines, you have n
2、othing to worry about. Go about your merry way and keep up the good work. In the unlikely event that such exposure has occurred, however, you need to be aware that it may cause the pumps motor to malfunction and significantly over-deliver insulin, causing severe hypoglycemia. As a result of this pot
3、ential, the FDA has, based upon Medtronics voluntary report, identified certain Paradigm pumps as subject to a Class II recall. (The action is described by Medtronic as a Class II field correction rather than a recall because no pump need be returned unless it has been actually damaged by magnetic e
4、xposure.) Medtronic reports that on April 24, 2007, the company sent a warning letter, enclosed in a red envelope, to 200,000 Paradigm pump purchasers, as well to 30,000 healthcare practitioners, including every prescriber of their pumps, and every one of the over 14,000 MRI facilities in the United
5、 States. The patient letter read as follows: Recently, we have become aware of cases where exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls the movement of the motor used in Medtronic MiniMedMiniMed Paradigm insulin infusion pumps. Altho
6、ugh the insulin pumps exhibited alarms as a result of this damage, in some cases, users have cleared these alarms and continued to use the pump. UnderUnder thesethese conditions,conditions, thethe insulininsulin pumppump willwill exhibitexhibit significantsignificant over-deliveryover-delivery ofof
7、insulin,insulin, potentiallypotentially causingcausing severesevere hypoglycemia.hypoglycemia. Medtronic MiniMedMiniMed (along with other insulin infusion pump manufacturers) has always cautioned users to avoid exposing their infusion pump to strong magnetic fields, such as those associated with MRI
8、 machines. Until recently, all testing has indicated this exposure would cause significant pump damage and prevent MiniMedMiniMed Paradigm insulin pumps from delivering any insulin following this exposure. However, we now know that significant over-delivery of insulin can occur following this exposu
9、re. In light of this new information, we are reminding insulin pump users not to expose your insulin pump to strong magnetic fields such as those generated by MRI equipment. YOURYOUR INSULININSULIN PUMPPUMP MUSTMUST BEBE REMOVEDREMOVED ANDAND KEPTKEPT OUTSIDEOUTSIDE THETHE PROCEDUREPROCEDURE ROOMROO
10、M IFIF YOUYOU AREARE UNDERGOINGUNDERGOING MRI.MRI. If the insulin pump is damaged by exposure to a high strength magnetic field, the insulin pump will typically provide multiple and frequent alarms such as “motor error“ alarms (especially after rewind), A35A35 alarms and A43 alarms. In addition, the
11、 pump will no longer provide a “low reservoir“ alert prior to an empty reservoir and the actual volume in the reservoir will be less than the amount displayed on the pumps status screen. IFIF YOUYOU SUSPECTSUSPECT THETHE PUMPPUMP MAYMAY HAVEHAVE BEENBEEN EXPOSEDEXPOSED TOTO MRIMRI OROR OTHEROTHER VE
12、RYVERY STRONGSTRONG MAGNETICMAGNETIC FIELD,FIELD, DISCONTINUEDISCONTINUE USEUSE OFOF THETHE PUMPPUMP ANDAND CONTACTCONTACT THETHE MEDTRONICMEDTRONIC MINIMEDMINIMED 24-HOUR24-HOUR HELPHELP LINELINE ATAT 800-826-2099800-826-2099 FORFOR FURTHERFURTHER ASSISTANCE.ASSISTANCE. Please note that MiniMedMini
13、Med Paradigm insulin infusion pumps have undergone extensive testing with devices such as airport metal detectors, electronic article surveillance equipment and cellular phones and we have confirmed that exposure to these devices will not adversely affect pump operation. If you have any additional q
14、uestions regarding this letter or any other questions regarding our products, please feel free to contact the Medtronic MiniMedMiniMed 24-Hour Help Line at 800-826-2099. Nearly three months later, in its July 11, 2007, weekly Enforcement Report, the FDA announced that Medtronic had initiated action
15、regarding Paradigm pumps that the FDA categorized as a Class II recall. The FDA report read as follows: PRODUCTPRODUCT: Medtronic MiniMedMiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712712, MMT-515, MMT- 715, MMT-522 and MMT-722, Recall # Z-1007-20
16、07 CODECODE: All serial numbers for the following Paradigm models: MMT-51 1, MMT-512, MMT-712712, MMT-515, MMT-715, MMT-522 and MMT-722 RECALLINGRECALLING FIRM/MANUFACTURERFIRM/MANUFACTURER: Medtronic MiniMedMiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing. REASONREASON: Exposure to Magnetic Resonance Imaging (MRI) h
