dimarts, 7 de març del 2017

Maquet warns on venting battery issues with Cardiosave balloon pumps

Maquet

Getinge‘s (PINK:GETI B) medical subsidiary Maquet Cardiovascular recently issued an urgent product recall notice for its Cardiosave intra-aortic balloon pump over issues with its lithium ion batteries sparking or smoking after being dropped.

In an urgent product recall notice, the company said it has received 3 reported occurrences of the batteries venting when dropped, creating the potential for smoke, foul odors and sparks.

So far, Maquet said it has had no reports of adverse health events in relation to the battery venting.

The recall notice affects lithium-ion batteries used with its Cardiosave hybrid IABP and its Cardiosave rescue IABP with part number 0146-00-0097, distributed between Dec. 12, 2011 and Nov. 9, 2016.

Maquet urged users of the device to take extra care to avoid dropping batteries for the devices, and to insure that 2 batteries are fully charged and installed in the IABP console prior to use. The company also instructed users to not carry spare batteries during transport of the devices, and instead use an inverter and transport AC power supply.

The company said that batteries that are already properly installed are not affected by the drop risk. Representatives are slated to visit on-site to affix “do not drop” labels to batteries, the company added.

Last October, Maquet released a field safety notice over issues with bacterial contamination associated with its surgical heater-cooler units. The warning affects its HCU 20, HCU 30 and HCU 40 heater-cooler units and its HU 35 heater unit.

The company said that it, along with the national competent authorities in multiple countries, have received reports of mycobacterial contamination in the system water used by heater and heater-cooler devices.

 

The post Maquet warns on venting battery issues with Cardiosave balloon pumps appeared first on MassDevice.



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