MAUDE Adverse Event Report: NURSEL BOELENS CARDIOHELP-I; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701048012 - CARDIOHELP-I

Device Problem No Flow (2991)

Patient Problem Death (1802)

Event Date 02/17/2020

Event Type  Death  

Event Description

Customer called to let me know he had a problem with the cardiohelp device.The patient was on the cardiohelp for a number of days when during an operation for pulmonary embolism the event occurred.The perfusionist noted that the output flow of the cardiohelp dropped to below zero whilst maintaining rpm.Before during and after the event arterial pressures were 400mm hg or higher.The perfusionist then manually checked via the arterial sample port that there was no flow from oxygenator.The hls oxy was then placed into the hand crank where flow was restored.The customer then placed the same oxygenator into a new cardiohelp device flow was restored with no further incidents.It is noted that the patient was a complex case he had lymphoma and was suffering from a pulmonary embolism.Discussions with the customer it was revealed that one possible cause for the event was blocked venous return to oxygenator possible due to patient condition.The patient expired.(b)(4).

Manufacturer Narrative

A getinge service technician was onside and investigated the device in question.A repair was not performed.The log files were exported on 2020-02-18.The analysis was performed on by customer service (rastatt, germany) on 2020-02-21.According to the analysis the failure "pump disposable error - stop" occurred twice.That message will be displayed when the disposable will be removed during use.A medical review was performed on 2020-04-02.Conclusion: the final outcome, was patient death, however the hospital believes that the event with the cardiohelp did not contribute to this outcome and that the cause of death was due to existing patient condition.With the present information the opinion of the hospital staff cannot nullified.Although unlikely a device related incident cannot be entirely ruled out.The related disposable was not available for an investigation.Since a malfunction can be excluded, the failure could not be confirmed.As most probable root cause it could be determined that the patient expired due to its conditions.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.

Event Description

Complaint number: (b)(4).

• Brand Name: CARDIOHELP-I
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9742673
• MDR Text Key: 180463627
• Report Number: 8010762-2020-00078
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 701048012 - CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 126