MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was a patient accident on the rotaflow console reported.The patient expired.No more details provided and available at this time.Complaint id:(b)(4).

Manufacturer Narrative

The event occurred in the us.It was a patient accident on the rotaflow console reported.The patient was infected with covid 19 and the customer reported low ecmo flow.No error message or any alarm on the console were reported and the device was not exchange during treatment.The patient expired.The rotaflow console with (b)(6) was investigated by a getinge field service technician on 2021-10-07 and was unable to reproduce the reported failure.The unit passed all functional tests.The device was cleared for clinical use and was sent back to the customer.The reported failure and the application method described by the customer was evaluated by getinge medical affairs department on 2021-11-15 with following outcome: based on the limited information provided the reviewer concludes the unfortunate outcome of the patient may have been a result of a use error, patient co-morbidities prior to, and during therapy, and/or gaps in clinical management and monitoring.The principle complaint ¿low flow¿ included in the complaint report and correspondence does not establish causality or provide any insight into the root cause.There is no established association between the reported ¿low flow¿ event and a device failure.The service report concluded the rotaflow was fully functional and to specification.Conclusively, the reported outcome and the low flow state do not appear to be associated with a device failure or lack of performance.The flow set-point is determined by the end user.Flow setting is a critical metric that requires monitoring and clinical assessment.Immediate intervention is required by the clinician and is consistent with basic standards of care for all patients receiving extracorporeal life support.The possible root causes cannot be determined based on the available correspondence and would at minimum require careful review of the clinical record.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.The review of the non-conformities was performed on 2021-11-17 and during the period of 2009-06-01 to 2021-11-17 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 rotaflow console in question was produced in 2009-06-01.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12603639
• MDR Text Key: 275836893
• Report Number: 8010762-2021-00549
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death