(http://bme.freebbs.tw 醫學工程論壇 同步發表)
搭配使用GemStart使用的Pump座 ,國內沒特別註記有這款QSD申請,但個人認為有時會被認為是配件沒特別申請,直接建議使用,如果各位醫院裡有類似的裝置,建議還是問一下原廠,RECALL的處理狀況。
特別是如果沒QSD的話,要記得撤下勿使用。因為藥事法己修訂,零件、配件、軟體都歸屬QSD管制範圍。
((國內引進的型號13000,13150。13086, 13087, 13088))
Recall Class: Class I
Date Recall Initiated: February 18, 2014
Product: GemStar Docking Station (List Number 13075), used in conjunction with GemStar Infusion Pump
The GemStar Docking Station is a separately sold accessory to the GemStar infusion pump and provides an alternate power source to the GemStar pump
The affected GemStar Docking Station was manufactured from July 2002 through March 2013 and distributed from July 2002 through December 2013.
搭配使用GemStart使用的Pump座 ,會影響所使用的PUMP型號如下表
The products affected by this recall are identified below:
| Affected Docking Station ProductCode | When Used with These Models of Infusion Pumps | With the Affected List Numbers | May Result in the Following Malfunction |
|---|
| 13075 | GemStar Phase 3 Pumps | 13000, 13100, 13150 | Fail to Power Up |
GemStar Phase 3 Pumps or
GemStar Phase 4 Pumps | 13000, 13100, 13150
13086, 13087, 130088 | Error Code 11/003 |
Use: The GemStar Docking Station is used in the post-operative hospital setting where the GemStar pump provides pain/patient control anesthesia (PCA) infusion in combination with other GemStar Accessories. The GemStar pump is often used to inject anesthesia into the spine prior to giving birth. The GemStar pump can also be used for other general infusions such as IV medicines and feeding solutions, antibiotics and cardiovascular solutions.
Recalling Firm:
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Reason for Recall:
The firm received customer reports of two potential malfunctions that may occur with the GemStar Docking Station. To date, there have been no reports of death or serious injury associated with these malfunctions.
When the docking station is used with a GemStar Phase 3 pump (List 13000, 13100 or 13150), the GemStar pump may fail to power up while connected to the docking station which may cause a delay of therapy.
When a GemStar Phase 3 pump (List 13000, 13100 or 13150) or GemStar Phase 4 pump (List 13086, 13087 or 13088) is used with both a docking station and an external battery pack accessory (List 13073), there is a possibility that the GemStar pump will display error code 11/003 which will trigger an audible alarm, indicating excessive input voltage (more than 3.6 Volts). The pump will then stop the infusion which may cause a delay of therapy.
The use of this affected product may cause serious adverse health consequences, including death.
Public Contact: For further inquiries, please contact Hospira using the information provided below:
| Hospira Contact | Contact Information | Areas of Support |
|---|
Hospira Global Complaint
Management | 1-800-441-4100 (M-F, 8 am-5pm, CT)
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 |
FDA District: Chicago District Office
More Information about this Recall: On February 18, 2014, Hospira sent an Urgent Medical Device Correction letter to all its direct customers. Customers are requested to complete and sign the reply form and return it to the fax number or email address on the form.
Hospira recommends the following:
There is no need to return the GemStar Docking Station at this time.
Healthcare professionals should 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/of therapy could result in serious injury or death.
1. To avoid a failure to power up, turn the pump on first, before connecting the pump with the docking
station. This will prevent the failure to power up.
2. To mitigate the potential for an 11/003 error code, remove the External Battery Pack accessory (list #13073) from the Docking Station and pump prior to installing the pump into the Docking
Station. If you use a Docking station in conjunction with an External Battery Pack accessory (list #13073), this practice should not continue. Please contact Hospira to discuss an appropriate alternative option.
3. Inform potential users in your organization of this notification.
4. Should your facility experience a failure to power up or an 11/003 error code, report the issue to Hospira by calling 1-800-441-4100 (M-F, 8am-5pm,CT) or email
ProductComplaintsPP@hospira.com.
5. If you have distributed the product further to the retail level, notify your customers that received the product identified above of this notification and ask them to contact Stericycle at 1-
866-792-5451 (M-F, 8am-5pm ET) to receive a reply form.
About Class I Recalls: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 Program either online, by regular mail or by FAX.
Additional Resources:
E-MiniC
N-FC, N-FCREC
to their customers. The letter identified the affected products and problem and provided safety instructions. Customers should read the letter and follow the instructions provided.
