- Sigma Spectrum Infusion System Master Drug Library User Manual Test
- Sigma Spectrum Infusion System Master Drug Library User Manual Guide
The SIGMA Spectrum Infusion System eLearning modules provide a comprehensive education program intended to supplement the in person training received from Baxter trained clinicians. Baxter offers a robust portfolio of eLearning modules to refresh your SIGMA Spectrum Infusion pump and master drug library (MDL) training when it is convenient for you. Apr 16, 2013 Subject: SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) Dear Customer, On April 1, 2013, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Baxter Healthcare Corporation regarding the 510(k) clearance status of modifications made to the SIGMA Spectrum Infusion Pump with MDL since its initial clearance. The SIGMA Spectrum Infusion System was designed with features to help reduce errors when programming an IV infusion. Intended for Canadian audiences only The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of intravenous fluids.
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Sigma Spectrum Infusion System Master Drug Library User Manual Test
| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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Sigma Spectrum Infusion System Master Drug Library User Manual Guide
| New Search | Back to Search Results |
| | Class 2 Device Recall Sigma Spectrum Infusion Pump with master Drug Library Version 6. |
| Date Initiated by Firm | April 03, 2018 |
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| Date Posted | May 04, 2018 |
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| Recall Status1 | Completed |
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| Z-1667-2018 |
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| Recall Event ID | 79815 |
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| K042121 |
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Pump, infusion - Product CodeFRN
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| Product | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE
Product Usage:
The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
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| Code Information | Serial number 758477 |
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Recalling Firm/
Manufacturer | Baxter Healthcare Corporation
711 Park Ave
Medina NY 14103-1036
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| For Additional Information Contact |
800-422-9837 |
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| Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. |
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| Employee error |
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| On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail. Actions to be Taken by Customers: 1. Locate and discontinue use of all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or via email to fca@baxter.com even if you do not have inventory. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers. |
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| 444 units in total |
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| US Nationwide & Puerto Rico |
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| TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. | | 510(K) Database | 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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