Model Number CARDIOHELP-I |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problems
Ischemia (1942); Insufficient Information (4580)
|
Event Date 05/18/2022 |
Event Type
Injury
|
Event Description
|
Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical device on 2023-03-01: the vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by , occurred on 2022-05-18.It was reported that there was a ischemia of the left lower extremity.Complaint id#: (b)(4).
|
|
Manufacturer Narrative
|
A follow-up medwatch will be submitted when additional information becomes available.
|
|
Manufacturer Narrative
|
Maquet cardiopulmonary gmbh has received the following information from the spanish agency of medicines and medical device on 2023-03-01: the vigilance area of medical devices of the spanish agency of medicines and medical devices has been informed through renacer registry about an incident involving the product ¿cardiohelp system¿, manufactured by getinge and distributed by , occurred on 2022-05-18.It was reported that there was a ischemia of the left lower extremity.Further information regarding the event and the involved product has been requested by getinge sales and service unit (ssu) however, no further information was provided by the customer after several attempts.Based on the results the reported failure "ischemia lower extremity" could not be confirmed.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe for review between 2022-03-01 and 2023-03-01).The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.H3 other text : no further information from customer.
|
|
Event Description
|
Complaint id# (b)(4).
|
|
Search Alerts/Recalls
|