Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Enforcement
- Recall Number
- Z-0589-2016
- Event ID
- 72652
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Maquet Cardiovascular Us Sales, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 13, 2016
- Initiation Date
- November 13, 2015
- Classification Date
- January 5, 2016
- Termination Date
- April 7, 2017
- Address
- 45 Barbour Pond Drive, N/A, Wayne, NJ, 07470, United States
Description
Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.
HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001.
United States Nationwide Distribution
100 Units (distributed in United States)