SIGMA 8000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-10 for SIGMA 8000 * manufactured by Sigma International.

Event Text Entries

[311923] Recent preventative maintenance rounds have revealed a very significant percentage of chassis integrity failures on several plastic chassis devices. Over 10% of the sigma 8000 general purpose infusion pump fleet, and comparable numbers of baxa syringe pumps and hugs infant abduction transmitter tags have been found to exhibit degradation of chassis plastic. In the worst cases, the plastic degradation resulted in small corners of the chassis breaking away, allowing fluids penetration and consequential operational failures. The manufacturers have attributed the problem to use of numerous cleaning/antiseptic solutions not approved for use on their devices. Further follow up revealed that the facility uses blue sky ii, which is in a controlled dilution dispenser used by environmental services, and heptagon, which is in a ready-to-use formula used by nursing floors. Sigma in it's users manual for the model 8000 general purpose infusion pump indicates: "the following cleaners and disinfectants may be used: 1) 70% to 90% ethyl or isopropyl alcohol in water. 2) 10% bleach in water. 3) sodium hypochlorite cleaner disinfectant such as: 1)dispatch by caltech industries inc. 2) quaternary based germicidal detergent such as: a) t. B. Q. By calgon vestal labs, b) hi-tor plus by huntington lab. S, c) sani-turge 256 by purex industrial corp. " baxa in it's users manual for the microfuse dual rate infuser indicates under cleaning and disinfection: "exterior infuser surfaces may be cleaned using a damp cloth and mild detergent. Use a mild germicide to disinfect. The infuser cannot be immersed or flushed with any solution. Do not sterilize using eto gas or steam autoclave. " hugs in it's users literature for its anti-abduction devices indicates that for cleaning, "use a soft-bristle brush and a disinfectant soap or solution with no more than 20% alcohol. Some acceptable cleaners are 1) heptagon disinfectant cleaner, 2) kleenaseptic from metrex research corporation, 3) metriwipes germicidal cloths, 4) cavicide disinfectant solution,5) hibiscrub, or 6) hibitane anti-bacterial solutions. " the facility was using the hugs recommended heptagon cleaning solution on this product when the plastic failure was noted. The company has now come to the conclusion that heptagon, while listed with their acceptable cleaners, is not compatable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 557062
• MDR Report Key: 557062
• Date Received: 2004-11-10
• Date of Report: 2004-11-10
• Report Date: 2004-11-10
• Date Reported to FDA: 2004-11-10
• Date Added to Maude: 2004-12-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SIGMA
• Generic Name: GENERAL PURPOSE INFUSION PUMP
• Product Code: FRN
• Date Received: 2004-11-10
• Model Number: 8000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 546733
• Manufacturer: SIGMA INTERNATIONAL
• Manufacturer Address: 711 PARK AVE. MEDINA NE *1036 US
• Baseline Brand Name: SIGMA 8000
• Baseline Generic Name: INFUSION PUMP
• Baseline Model No: 8000
• Baseline Catalog No: 35001
• Baseline ID: NA
• Baseline Device Family: SIGMA 8000 INFUSION PUMP
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K942162
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: MICROFUSE DUAL RATE INFUSER
• Generic Name: SYRINGE PUMP
• Product Code: FRN
• Date Received: 2004-11-10
• Model Number: MICROFUSE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 546734
• Manufacturer: BAXA CORPORATION
• Manufacturer Address: 14445 GRASSLANDS DR. ENGLEWOOD CO 801123903 US

Device Sequence Number: 3

• Brand Name: HUGS INFANT PROTECTION
• Generic Name: ANTI-ABDUCTION DEVICE
• Product Code: NOD
• Date Received: 2004-11-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 546735
• Manufacturer: XMARK
• Manufacturer Address: 808 COMMERCE PARK DRIVE OGDENSBURG NE * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-11-10