MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number CARDIOHELP-I |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Cardiac Arrest (1762)
|
Event Date 11/30/2022 |
Event Type
Death
|
Manufacturer Narrative
|
A getinge field service technician (fst) was sent for investigation on (b)(6) 2022.No malfunction of the device was found therefore no part was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The affected hls set will be investigated in complaint# (b)(4).A follow-up medwatch will be submitted when additional information becomes available.
|
|
Event Description
|
The event occurred in usa during treatment.Following was initially reported:the hls module advanced performed as it was designed.It was reported that a large amount of air entered the venous air from an unknown source.Once the centrifugal pump saw that amount of venous air it triggered an automatic pump stop.The ecls provider assigned to the case wasn't able to resolve the venous air situation on their own, so the ecls coordinator was called down to help, when arrived at the patient he had been off support for longer than 6 minutes.It was noted that the air was removed from the venous line, and the circuit was again ready to be used in the proper manner.Unfortunately, the medical providers determined that too much time had passed from the time the patient went off support to the time the circuit was again ready for use.A decision was made to withdraw mechanical hls and cardiohelp support from the patient.Subsequently the patient expired.The hospital was performing an autopsy.The providers conducting the autopsy also performed an underwater test on the hls module advanced and they determined that the circuit didn't have any leaks or compromised integrity of any kind.The ecls coordinator also informed that she had sequestered the cardiohelp that was used during the case.Getinge service technician was contacted and is scheduled to perform an inspection and information download of the cardiohelp on (b)(6) 2022.Complaint id# (b)(4).
|
|
Event Description
|
Complaint id# (b)(4).
|
|
Manufacturer Narrative
|
It was reported that a large amount of air entered the venous line from an unknown source.Once the centrifugal pump recognized an amount of venous air, it triggered an automatic pump stop.It was told that the ecls provider, who was assigned to the case was not able to resolve the venous air situation on his own, therefore the ecls coordinator was called down to help.Once he arrived the patient had been off support for longer than 6 minutes.It was noted that the air was removed from the venous line, and the circuit was again ready to be used in a proper manner.Unfortunately, the customer determined that to much time had passed from the time the patient went off support to the time the circuit was again ready for use.A decision was made from the customer to withdraw mechanical hls and cardiohelp support from the patient.Subsequently the patient expired.The customer was performing an autopsy.In the autopsy an underwater test on the hls module advanced was performed and they determined that the circuit didn't have any leaks or compromised integrity of any kind.A getinge field service technician (fst) did multiple attempts to the customer.The customer confirmed that he performed an own internal investigation and found out that neither the hospital staff nor the devices have led to the event.Therefore the customer did not send the hls set back for investigation.The affected hls set was investigated in complaint# (b)(4) (mfg report number 8010762-2022-00489).A fst was sent for investigation of the cardiohelp device on 2022-12-05.No malfunction of the device was found therefore no part was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A medical review was performed on (b)(6) 2023 by getinge medical affairs with following conclusion: "the evaluation of the described event resulted in the conclusion that the cardiohelp and the hls set that where uses both worked as expected.The customer stated after performed testing and autopsy that no evidence was found to implicate the hls module or the cardiohelp as a potential cause for the event.The root cause of the air entrancement remains unclear.Most likely possibilities of air entrancement would be the following.Venous cannula dislocated or disconnected from the circuit.Air inside the venous system of the patient that was entrained into the pump" the review of the non-conformities has been performed on 2022-12-06 for the period of 2017-09-01 to 2022-12-05.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2017-09-01.Based on the results the reported failure "air in venous line" could be confirmed, but was not related to a device malfunction.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2021-12-05 till 2022-12-05).The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.
|
|
Search Alerts/Recalls
|
|
|