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 Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2022

Event Type  malfunction  

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 reported the rotaflow console with s/n 94176024 displayed the error message ¿head error¿ during patient treatment.The staff switched to hand cranking on the patient, then switched to another rotaflow unit.This unit also displayed the error "head error" message at first, but ecmo specialist in attendance did notice the pump appeared to be operating.However, they elected to resume hand cranking on this second unit.No information was available about which unit was used for this portion of the support.The customer wiped down behind the pump head (even though nothing as visibly wrong) and when they switched back to pumping with this second rotaflow console, everything worked normally.Eventually they switched therapy to a cardiohelp unit.There was no noted negative impact to the patient and pressures and vitals were all monitored and considered appropriate during the incident.More information requested but still pending.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.This complaint is connected to the beq-rf-32-usa#: rotaflow zentrifugal complaint id#: (b)(4).It was reported that the rotaflow console with s/n: (b)(6) displayed the error message ¿head error¿ during patient treatment.The hospital staff moved the pump head (rf-32 centrifugal pump complaint id#: (b)(4) over to a hand crank, brought in a second rotaflow console with s/n: (b)(6) and initiated pumping on the second unit.They noted that pump seemed to be pumping normally but the same "head error" appeared on the second rotaflow console.The same rotaflow pump head (rf-32 centrifugal pump) was moved again to the hand crank and the customer decided to switch to cardiohelp-i and hls set.There was no noted negative impact to the patient and pressures and vitals were all monitored and considered appropriate during the event.No harm to any person has been reported.A getinge field service technician investigated the rotaflow console with s/n: (b)(6) and was able to confirm the reported "head error".The rotaflow console (rfc) control board pcba (printed circuit board assembly) kit (article number: 701034051) has been replaced.Additionally, the batterypack ni-cd 24v 132wh (rfc) (article number: 701017188) has also been replaced as part of the maintenance.After the replacement the device is working as intended.Getinge sales and service unit (ssu) confirmed on 2023-02-06 that the replaced rfc with s/n: (b)(6) showed a problem when trying to swap over the rf-32 centrifugal pump.The hospital staff solved the problem by removing and re-installing the rf-32 centrifugal pump.The unit worked properly afterwards.The rfc with s/n: (b)(6) was tested and found working according to manufacturer¿s specifications.Thus, the reported failure could not be confirmed for the rfc with s/n: (b)(6) but for the rfc with s/n: (b)(6).The following most possible root causes could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.If the rpm / lpm is set to zero and the drive as well as the inserted centrifugal pump is shaken this causes magnetic uncoupling of the centrifugal pump and thus leads to the head error.This error can be overwritten by restarting the rota flow console.Rotaflow console s/n: (b)(6): the review of the non-conformities was performed on 2022-12-22 and during the period of 2020-05-01 to 2022-12-22 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 with s/n: (b)(6) was produced in 2020-05-01.Rotaflow console s/n: (b)(6): the review of the non-conformities was performed on 2023-02-07 and during the period of 2020-05-01 to 2023-02-07 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 with s/n: (b)(6) was produced in 2015-09-15.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.Chapter 4.1.3: 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.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).Complaint is connected with 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: 16033884
• MDR Text Key: 306440947
• Report Number: 8010762-2022-00514
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1