BIEGLER BW385L BLOOD & INFUSION WARMER

K954769 · Biegler Medical Products, Inc. · LGZ · Aug 8, 1996 · General Hospital

Device Facts

• Record ID: K954769
• Device Name: BIEGLER BW385L BLOOD & INFUSION WARMER
• Applicant: Biegler Medical Products, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Aug 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature.

Device Story

Device warms blood and IV fluids to approximate body temperature; prevents complications from cold fluid infusion. Operates via 400W heating element and metal cylindrical heat exchanger with grooves. IV tubing wraps around exchanger; fluid heats as it flows through tubing. Device features LED temperature monitor; on-off switch; dual knob clamp for IV pole attachment. Used in clinical settings; operated by healthcare professionals. Benefits patient by maintaining normothermia during fluid administration.

Clinical Evidence

Bench testing only. Data compiled at 21°C ambient temperature using initial fluid temperatures of 18°C and 7°C. Results indicate the device adds sufficient heat to the liquid medium at infusion rates up to 6 liters/hour to approximate normal body temperature.

Technological Characteristics

Dry-wall channelled metal heat exchanger; 400 Watt heating element. 120V/220V AC power source. Weight: 2.5 Kg. Form factor: cylindrical exchanger with grooves for IV tubing. UL/C-UL approved; CSA certified.

Indications for Use

Indicated for patients requiring infusion of blood or other liquids, where warming the infusate to approximate body temperature is necessary to reduce complications associated with the infusion of fluids cooler than normal body temperature.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• DW1000 (Baxter)
• Hotline (Level 1)
• FloTem (DataChem)
• Fenwal (Baxter)

Submission Summary (Full Text)

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BIEGLER BW385L [510(K)]
BIEGLER medical products inc.
X954769

Section Six
510(K) Summary

AUG - 8 1996

Date: September 27, 1995.
Submitter: Biegler Medical Products Inc.
Contact: Martin Costello
Trade Name: Biegler BW385L Blood & Infusion Warmer
Common Name: Infusion and/or Blood Warmer
Classification Name: Warmer [Classification Names for Medical Devices & In Vitro Medical Diagnostic Products]

The Biegler BW385L Blood & Infusion Warmer is designed to reduce complications associated with the infusion of blood and other liquids that are cooler than normal body temperature. The BW385L warms the fluid by means of a metal Heat Exchanger which is adjacent to an I.V. Tubing Extension Set through which the fluid to be heated flows. The cylindrical Heat Exchanger has a series of grooves; the Extension Set tubing is 'wrapped' around the Exchanger and into these grooves. The BW385L operates on a 120 volt (or where required 220 Volt) A.C. power source and is controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED temperature monitor. The BW385L Blood & Infusion Warmer weighs 2.5 Kg. and is equipped with a dual knob clamp at the back of the instrument for I.V. pole attachment. The infusate is warmed to approximate body temperature as it travels a path around the constantly monitored and regulated Heat Exchanger. The BW385L is UL / C-UL approved and units placed to date have received special CSA inspection certification.

The Biegler BW385L Blood and Infusion Warmer has the same intended use as several devices now marketed in the U.S. The DW1000, Baxter; the Hotline$^{R1}$, Level 1; the FloTem$^{R2}$, DataChem and the Fenwal$^{R3}$, Baxter are all used to heat infusate. The Hotline uses a fluid heat exchange system while the others utilize 'dry-wall' Heat Exchangers. The DW1000 has a cylindrical, metal, heated Exchanger over which a plastic cuff is fixed. The infusate is heated as it flows through this cuff. The Fenwal envelopes the infusate 'bag' between heated, metal exchanger plates. The FloTem Heat Exchanger is channelled allowing I.V. tubing to be fitted into the grooves. The four aforementioned warmers operate by means of heating elements that range from 300 to 360 Watts. These units provide sufficient heat for the fluid to approximate normal body temperature distal to the warmers.

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P.O. Box 160, Carlisle, Ontario, Canada L0R 1H0
Tel: [phone] FAX: [phone]

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BIEGLER BW385L [510(K)]

## Section Six (Summary continued)
### 510(K) Summary

The BW385L by comparison has a dry-wall channelled Heat Exchanger heated by a 400 Watt element. Data compiled by Biegler G.m.b.H. using the BW385L Blood & Infusion Warmer with Biegler Extension Sets, ambient temperature of 21 oC., with liquids at initial temperatures of both 18 oC. and 07 oC. indicate that at moderate infusion rates (to 6 litres / hour) the BW385L adds sufficient heat to the liquid medium to claim substantial equivalence to the warmers mentioned above.