Recall Z-0589-2016 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Maquet Cardiovascular Us Sales, Llc
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.
| Date | Jan 5, 2016 (initiated Nov 13, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to HCU30@maquet.com; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service |
| Quantity | 100 Units (distributed in United States) |
| Distribution | United States Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031544 | HEATER COOLER UNIT, MODEL HCU 30 Jostra AB, Aug 7, 2003 |