MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Failure to Read Input Signal (1581); Failure to Deliver (2338); Failure to Infuse (2340); Pumping Problem (3016)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

In relation to a opened support case four failures were reported: ¿venous probe displayed data questionable¿, ¿device defective (0xd00e)" , ¿rpm control error¿ and ¿pump disposable error-stop".The technician recognized the failures during inspection of the logfiles.A review of complaints data shows no complaints were found in regards to this affected serial no.A getinge service technician (fst) was sent for investigation and repair on 2022-05-02 and 2022-05-05.No parts were replaced.In relation to the support case all accessible internal electrical connections on the sensor panel were removed and reseated.The failures could not be reproduced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Based on the evaluated facts above, the reported failures were confirmed during inspection of the logfiles, but could not be reproduced by the fst.As no parts were replaced, no technical investigation could be performed.However, according to the current risk file following root causes can lead to the reported failures: root cause reported failure: "device defective": failure in electronic components of drive component (e.G.Wear / loosening of components): communication to motion controller disturbed, wrong direction of pump drive, wrong speed and wrong flow direction (tubes).Root cause reported failure: "venous probe displayed data questionable": (partly) sensor failure, wrong measurement values caused by sediments in the disposable, light influences, blood light spectrum differences and response time is too long.Root cause reported failure: "rpm control error": failure in electronic components of drive component (e.G.Wear / loosening of components): communication to motion controller disturbed, wrong direction of pump drive, wrong speed and wrong flow direction (tubes).Root cause reported failure: "pump disposable error": user does not perceive or recognize how to correctly mount the transport guard, the transport guard are mounted incorrectly or not mounted at all and no coupling or insufficient coupling between the cardiohelp device and the disposable during transport.Additional condition: the mechanical impact on the cardiohelp device and disposable is too high.According to the instruction for use (ifu), chapter 9 (messages) the customer should continually check the perfusion on the cardiohelp-i and by monitoring the patient.If necessary the perfusion has to be continued with the emergency drive and the cardiohelp-i has to be replaced as quickly as possible.The cardiohelp-i should taken out of service.According to chapter 5.6.1 "check before every application" the functionallity of the cardiohelp needs to be checked before every use.In the instruction for use (ifu) is stated that it is necessary to decrease the flow to zero before disconnecting and connecting the disposable to the device.The ifu (instructions for use | 1.8 | en | 09) of the cardiohelp includes a warning under chapter 2 "do not remove the disposable product during normal operation." furthermore in the ifu( instructions for use | 1.8 | en | 09) it is stated in chapter 2.1.4 "please refer to the respective instruction for use of the disposables".In reference of the current ifu for disposables (instructions for use | 1.5 | g-270 | 02) the following is stated in chapter 5.3.1 safety instructions for the oxygenator: incorrect installation of the hls module advanced can lead to device malfunction.This can endanger the patient.Use the device only together with the device cardiohelp-i.Install or remove the device only when the pump of the cardiohelp-i is at a standstill (0 rpm).Ensure that the device is fitted onto the device correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(4) , elo#: 1067320/v1) was reviewed on 2022-03-21.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on this investigation results, no product related malfunction could be confirmed.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.

Event Description

In relation to the opened support case four failures were reported: ¿venous probe displayed data questionable¿, ¿device defective (0xd00e)" , ¿rpm control error¿ and ¿pump disposable error-stop".The technician recognized the failures during inspection of the logfiles.A review of complaints data shows no complaints were found in regards to this affected serial no.The failures ¿device defective (0xd00e)" , ¿rpm control error¿ and ¿pump disposable error-stop" failures are high priority alarms of the cardiohelp.The pump will stop during treatment or a medical intervention will be necessary.Complaint number: (b)(4).

• Brand Name: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 14641515
• MDR Text Key: 302366381
• Report Number: 8010762-2022-00209
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1