Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification

FDA device recall Z-0146-2011 · posted 2010-11-05 · Terminated

Recall details

Recalling firm

Sigma International General Medical Apparatus, Llc

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

17,557 Infusion Pumps

Distribution

Nationwide Distribution

Date initiated

2010-09-15

Date posted

2010-11-05

Date terminated

2017-06-28

Location

Medina, NY

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