一級召修 Hospira Inc., GemStar Infusion System

(http://bme.freebbs.tw 醫學工程論壇同步發表)

Hospira Inc., GemStar Infusion System - Pressure Sensor Calibration Drift

＊＊＊ 衛署醫器輸字第009822號 ＊＊＊ 赫士睿" 寶星輸液暨疼痛處理幫浦

(國內引進的型號13000,13150。13086, 13087, 13088)

----今年5月才發布過鋰電池的Recall

Recall Class:  Class I
Date Recall Initiated:  March 15, 2013
Product:  Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088
All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 could be affected.(影響設備自2009.01.01以後製造或更換過壓力sensor的pump)

The pump's date of manufacture can be found on the Product Identity label located on the back of the pump.
Use: The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional foods and blood/blood products.  The device can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries.  When powered by batteries, the GemStar Pump is used for ambulatory patients.
Recalling Firm:
Hospira Inc. 275 North Field Drive Lake Forest, Illinois  60045-2579
Reason for Recall:  The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test(近遠端壓力sensor在作阻塞測試時會出現失敗時，可能就是校正值漂移), as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion:

• Cassette Check – D
• Cassette Check - P
• Proximal Occlusion  
• Distal Occlusion
• Pressure Calibration Error
• Bad Pressure Sensor Event
• Bad Pressure Sensor State
• Distal Pressure is Out of Range
• Proximal Sensor is Out of Range

(若有出現以上的Error Code,就有可能是壓力sensor校正值漂移)

A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.  This issue may also result in the pump shutting down.
Potential Risks:

• If these errors are observed, the infusion is stopped, resulting in delay/interruption in therapy.
• A full or partial occlusion may prevent fluid from reaching the patient, resulting in delay/interruption of therapy.
• An undetected distal occlusion may cause excessive pressure and fluid build-up within the distal line undetected by the pressure sensor. When the distal occlusion is resolved, the build-up fluid will be administered into the patient possibly causing a maximal over-infusion of <1.0 mL.
• The severity in the delay/interruption in therapy is dependent upon the underlying condition of the patient and the treatment being prescribed.  A delay/interruption in therapy has a worst case potential to result in significant injury or death.
• Depending on the drug and the dosage delivered, over-infusion has the worst-case potential to result in significant injury or death.

Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies.  Customers should consider the use of an alternative pump, particularly in patients in which a delay/interruption in therapy or an over-infusion could result in significant injury or death.
Public Contact: Call Hospira Advanced Knowledge Center at 1-800-241-4002, option 4 if you are unsure if the pressure sensor in your device has been replaced since January 1, 2009.
FDA District:  Chicago District Office
FDA Comments:

On March 15, 2013 Hospira sent its customers of record who purchased the device directly from them an "Urgent Device Field Correction¹" letter.  

Required Actions:

• Immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service. Contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM Central Standard Time) to report the issue and arrange for the return of the device for recalibration.
• Add the performance of a proximal and distal occlusion test to your yearly GemStar maintenance schedule.
• Complete and return the attached reply form and return it to the fax number or email address on the form, even if you do not currently have the impacted devices. Contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to obtain additional copies of the reply form.
• Notify your accounts who may have received these devices from you if you have further distributed them and ask that they contact Stericycle at 1-866-606-8264 (Monday- Friday, 8 AM - 5 PM Eastern Standard Time) to receive a reply form.

（可以要求代理商 請先依原廠維修手冊，進行近遠端壓力sensor阻塞測試，並列入年度保養維護項目，並將檢測結果回傳Hospira公司)

Hospira Actions:

• Hospira is modifying the GemStar Technical Service Manual to add proximal and distal occlusion tests annually to confirm that devices do not require recalibration.

For further inquiries, contact Hospira using the information provided below.

Hospira Contact	Contact Information	Areas of Support
Hospira Global Complaint Management	1-800-441-4100 (8AM-5PM CST, M-F) (ProductComplaintsPP@hospira.com)	To report adverse events or product complaints
Hospira Advanced Knowledge Center	1-800-241-4002, option 4 (Available 24 hours a day/7 days a week)	Additional information or technical assistance

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 Program² either online, by regular mail or by FAX.