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

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2023

Event Type  Death  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the customer had an issue with the cardiohelp pump.On 2023-09-25.The information was received, that an incident occurred with a child on the cardiohelp.No more details were provided.The failure occurred during treatment.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

The information was received on 2023-10-18 that the patient expired.A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that the customer had an issue with the cardiohelp pump and is requesting access to the logfiles.On 2023-10-10 the service and sales unit confirmed that there was no death and the patient is alive.Later on 2023-10-18 the information was received that the patient expired.A getinge field service technician (fst) was sent for investigation on 2023-11-02.No part was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed by getinge technical support and no error of the device could be confirmed on the date of event.A medical review was performed by getinge medical affairs on 2023-11-30 with following conclusion: "because few details have been disclosed about the event, it is challenging to address particular aspects of the complaint.Presuming that the event in question occurred (time-wise) as noted in the logfiles, a few assumptions may be drawn from the details available in the log file (i.E., service and user pool data).The following conclusions have been drawn: the assumed event (pump stop) occurred on 20.09.2023 @ 02:50:25 hrs.The event identifier for the pump stop (0x0000d00d) indicates that the centrifugal pump was stopped manually.There is no error indicated from the service pool data that occurred either immediately before or after the reported event.It appears that the hls module may have been replaced to the cardiohelp drive after sensor disconnection, but the hls module may not have been properly seated in the drive due to the elicitation of the pump disposable error ¿ stop message at 02:54:32 hrs.It is assumed that the sensor cable was reconnected to the hls module sometime after the pump disposable error ¿ stop message at 02:54:32 hrs.An attempt was made to restart the pump a total of three times (before and after the message pump disposable error ¿ stop message at 02:54:32 hrs).At 02:56:40 hrs, the sensor cable was removed for a second time from the hls module.It is assumed that the e-drive was likely deployed sometime after the sensor cable was removed from the hls module the second time at 02:56:40 hrs.The user activity (as indicated by the data point narrative) after the second removal of the sensor cable is unclear.In conclusion, it appears as if the pump stop reported by the user was initiated manually (as suggested by the service pool data).It is likely the event was an inadvertent action in a presumed unlocked device/user-interface state.Because of the data provided in the cardiohelp service pool, it is challenging to associate the reported pump stop to a malfunction of the cardiohelp.In comparison, a software-initiated (device-initiated) pump stop is shown for a pump disposable error ¿ stop message at 02:54:32 hrs.Is difficult to conflate the expiration of the patient to a malfunction or malperformance of the cardiohelp console given the expiration of the patient occurred 10 days after the reported event.Further, given the paucity of information, it is challenging to equate the report ended with the outcome of the patient, despite expiration occurring 10 days after the reported event.As mentioned previously, no further information is known about the event itself, the activities surrounding the reported event, the patient (viz.Comorbidities), or the expiration of the patient.Further, no information was divulged regarding the period of extracorporeal support (i.E., a start/stop time and date of support) so as to coordinate the reported event with other significant events occurring in the course of support." in the instruction for use of the cardiohelp (ifu chapter 5.6.1 ¿check before every application¿) it is mentioned that all important functions of the cardiohelp have to be checked before use.The review of the non-conformities has been performed on 2023-12-01 for the period of 2013-06-11 to 2023-09-21.It 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 device was manufactured on 2013-06-11.Based on the results the reported failure "pump stopped" could be confirmed, but was not related to a device malfunction.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.

• 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: 17938853
• MDR Text Key: 325720127
• Report Number: 8010762-2023-00501
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 11/30/2023
• Supplement Dates FDA Received: 10/19/2023; 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death