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

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

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 china.It was reported that the error ¿-12 v test¿ occurred on the rotaflow console during patient use.The console was replaced within 50 minutes with a backup device.The patient expired on (b)(6) 2022.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that the error ¿-12 v test¿ occurred on the rotaflow console during patient use.The console was replaced within 50 minutes with a backup device.The patient expired on (b)(6) 2022.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the technician was able to reproduce the reported failure "error -12v".The mcp00702711#power supplyboard for rfc (rotaflow consol) (article number 701011675) and the mcp00702707#flow measure board for rfc (article number 701011681) has been replaced.After the replacement the device is working as intended.The review of the non-conformities was performed on (b)(6) 2022 and during the period of 2019-03-01 to (b)(6) 2022 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 2019-03-01.The root cause investigation of the manufacturer is still ongoing.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The affected parts mcp00702707#flow measure board for rfc (rotaflow console) (article number 701011681) and mcp00702711#power supply board for rfc (rotaflow console) (article number 701011675) has been requested for further investigation.The mcp00702711#power supply board was no longer available therefore, only the mcp00702707#flow measure board has been returned.The affected part mcp00702707#flow measure board for rfc (rotaflow console) (article number 701011681) was send back to the manufacturer for investigation.The part was investigated by the getinge life-cycle-engineering (lce) with the following outcome: a rotaflow flow measurement board was under investigation after it was reported that the device displayed the message ¿error -12vtest¿ during application.During the investigation the reported failure could be confirmed.The root cause was identified as a defective capacitor that has a reduced resistance.This led to an overload of the -12v grid that blew the fuse on the flow measurement board and presumably on the power supply board (which was not avaiable for investigation).A medical review was requested but still pending.

Manufacturer Narrative

The reported failure and the application method described by the customer was evaluated by getinge medical affairs on 2022-11-16 with the following outcome: the evaluation of the existing data has shown that the root cause for the described error message was identified as a defective capacitor that caused a reduced resistance.This consequently led to an overload of the -12v grid that triggered the fuse on the flow measurement board and presumably on the power supply board (psb).Unfortunately, the psb was not available for investigation.According to the rotaflow instruction for use (ifu), the -12vtest alarm would cause a pump stop and therefore the need to reestablish the blood flow of the patient.The product ifu recommends keeping the emergency dive at the ready for stop-gap in the event of a pump drive failure.The root cause of the failure was identified as a defective capacitor that had a reduced resistance.This led to an overload of the -12v grid that blew the fuse on the flow measurement board and presumably on the power supply board that was not available for investigation.It is possible that the cause for the defective capacitor may have been related to a hot-swap of the rotaflow drive power cable during the use.While the malfunction of the device may have contributed to the outcome of the patient, prompt use of the emergency drive may have mitigated the described outcome.The emergency drive is intended to be used in similar circumstances (viz.If the primary device malfunctions) to maintain necessary blood flow.Based on the investigation results the reported failure "error -12vtest" could be confirmed.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15 2.2.4 general precautionary measures during use always keep the rotaflow emergency drive at the ready for stop-gap manual operation in the event of pump drive failure.4.1.3 installing the rotaflow drive switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.In the event of a total failure of the rotaflow due to unforeseeable interferences or malfunctions, the centrifugal pump must be driven manually using the rotaflow emergency drive.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: 14731657
• MDR Text Key: 294255057
• Report Number: 3008355164-2022-00017
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2022
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2022
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death