New Major issue with certain pumps...FDA notice attached

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Retired Mom
Veteran Member


Date Joined Feb 2010
Total Posts : 1753
   Posted 2/16/2011 9:46 PM (GMT -6)   
I hope this is not violating any rules or regulations, but I receive updates from the FDA and other sites when recalls and warnings are issued.  I recieved the following this afternoon. (I do not have a pump, but I know some of you do). 
 
Moderators, please remove this if I have violated any policy or recommendation. 
 

Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall

AUDIENCE: Hospital Risk Manager

ISSUE: Pocket fills (the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
Products Affected:

  • SynchroMed II (Model No: 8637)
  • SynchroMed EL (Model No: 8626 and 8627)
  • Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)

BACKGROUND: The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient’s body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception of Medtronic MiniMed Infusion Pumps.

RECOMMENDATION: Medtronic reminded healthcare professionals to check needle placement within the pump septum during the drug refill procedure. According to Medtronic, it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At every refill, patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose, and withdrawal.

The hyperlink to read this directly is: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyalertsforHumanMedicalProducts/ucm243686.htm


Chartreux
Veteran Member


Date Joined Aug 2006
Total Posts : 9664
   Posted 2/17/2011 1:24 PM (GMT -6)   
I don't view this as a violation of any rules, it's intended
to inform, so Thanks for the up-date, retiredMom...
Healing hugz to all....
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* So many dx's I could write a book* "It would be nice if we could use the edit button in real life"...
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straydog
Forum Moderator


Date Joined Feb 2003
Total Posts : 16796
   Posted 2/17/2011 2:10 PM (GMT -6)   
RM thank you so much for posting this and no, you are not in any rule violation for this either. This kind of thing is good for people to know about.
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