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U.S. Department of Health and Human Services

Class 1 Device Recall Sigma Spectrum VOLUMETRIC INFUSION PUMP

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 Class 1 Recall
Sigma Spectrum VOLUMETRIC INFUSION PUMP
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Date Posted November 05, 2010
Recall Status1 Open
Recall Number Z-0146-2011
Recall Event ID 56833
Premarket Notification
510(K) Number
K042121 
Product Classification Pump, Infusion - Product Code FRN
Product Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.
Code Information Serial Numbers ranging from 706497 through 724065: 706497, 706498, 706499, 706500, 706501, 706502, 706503, 706504, 706505, 706506, 706507, 706508, 706509, 706510, 706511, 706512, 706513, 706514, 706515, 706516, 706517, 706518, 706519, 706520, 706521, 706522, 706523, 706524, 706525, 706526, 706527, 706528, 706529, 706530, 706531, 706532, 706533, 706534, 706535, 706536, 706537, 706538, 706539, 706540, 706541, 706542, 706543, 706544, 706545, 706546, 706547, 706548, 706549, 706550, 706551, 706552, 706553, 706554, 706555, 706556, 706557, 706558, 706559, 706560, 706561, 706562, 706563, 706564, 706565, 706566, 706567, 706568, 706569, 706570, 706571, 706572, 706573, 706574, 706575, 706576, 706577, 706578, 706579, 706580, 706581, 706582, 706583, 706584, 706585, 706586, 706587, 706588, 706589, 706590, 706591, 706592, 706593, 706594, 706595, 706596, 706597, 706598, 706599, 706600, 706601, 706602, 706603, 706604, 706605, 706606, 706607, 706608, 706609, 706610, 706611, 706612, 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Recalling Firm/
Manufacturer
Sigma International General Medical Apparatus, Llc
711 Park Avenue
Medina, New York 14103-1036
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Daniel J. Wellington
800-356-3454 Ext. 234
Manufacturer Reason
for Recall
The infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion.
FDA Determined
Cause 2
DESIGN: Device Design
Action Urgent: Medical Device Recall Notification letters and forms (dated 9/14/10) were sent to the consignees via Certified Mail on/about 9/15/10. The letters inform the consignees of the recall of the pumps since these units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. Consignees are instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to possible bearing failure, SIGMA is taking the precautionary measure of servicing or replacing all affected Spectrum Infusion Pumps and is requiring the return of the recalled devices to its facility. SIGMA has provided the following instructions for users: (1) Do not use the affected Spectrum Infusion Pumps on patient populations where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death. (2) Do not use on neonatal patients. -- If the user facility has no acceptable alternative methods for delivering therapy, the user should weigh the risks and benefits for the continued use of the affected pumps. If you must use these pumps, SIGMA recommends the following actions which may mitigate the risk. (1) for pediatric and adult patients, an add-on Buretrol may limit the amount of an over-infusion if the failure occurs. Always follow the Buretrol manufacturer's instructions. (2) consider using air-eliminating filters. Under free flow conditions pumps cannot stop fluid flow. If air is in the line with fluid, the air will also infuse. (3) Frequently observe that the drip rate (mL/hr) compares to the programmed pump flow rate. Also, make an observation of the container volume to make sure it is correct. If a discrepancy is observed, immediately remove the pump from service and treat the patient as appropriate. There are additional instructions to Asset Management Customers: SIGMA requests that each A.
Quantity in Commerce 17,557 Infusion Pumps
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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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