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

FDA device recall Z-1490-2012 · posted 2012-06-13 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

Recall expansion; 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. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

Action taken

Sigma sent an URGENT Medical Device Recall Notifications letter dated July 6, 2011 via UPS mail the consignees informing them of the expansion of the Spectrum Infusion Pumps recall. Some consignees were notified by telephone. The letter identified the affected product, problem, actions to be taken, clinical precautions and recommendations. Additional information regarding this voluntary recall is available on Sigma's web site www.sigmapumps.com/Recall. Customers were provided the following instructions: (1) Confirm that you have the affected serial number(s) ranging from 700000 to 794213 in inventory using the Customer Response Form. Refer to attached list of known affected devices in your possession. Revise this list as required. (2) Immediately remove affected pumps from neonatal use until B. Braun BC 1000 back check valves are employed. (3) Respond to this notification within five (5) working days of receipt by faxing the enclosed Customer Response Form to the number noted on the form, calling (866) 482-2893 between the hours of 8am and 8pm (EDT) or e-mailing a scanned version of form to sigma2407@stericycle.com. (4) Within three weeks of receipt of the Customer Response Form, (which verifies the device serial numbers in your facility), SIGMA will issue a customized recall report for each facility identifying the specific affected serial numbers, SIGMA internal contacts, and the plan for coordination of pump return and repair. For any adverse reactions experienced with the use of this product should be reported to SIGMA at (800)-356-3454 ext. 300 and to FDA MedWatch either by: Phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178; Mail at MedWatch, FDA 5600 Fishers Lane, Rockville, MD 20857, or MedWatch website by linking to: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

63,225 pumps total (corrected number): Domestic - 63,032 pumps; Canada - 29 pumps; Okinawa - 164 pumps

Distribution

Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of Canada and Okinawa

Date initiated

2011-07-06

Date posted

2012-06-13

Date terminated

2017-10-17

Location

Medina, NY

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