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

Model Number CARDIOHELP-I

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Exsanguination (1841); Insufficient Information (4580)

Event Date 12/05/2023

Event Type  Death  

Event Description

It was reported that a critical patient incident occurred due to a mechanical failure during ecmo.On 2023-12-07 the information was received that the patient did not survive.Complaint id# (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation on 2023-12-10/12.No part was replaced as no mechanical failure could be verified.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that a critical patient incident occurred due to a mechanical failure for ecmo cardiohelp, and the device is quarantined.On 2023-12-07 the information was received that the patient did not survive.New information was received on 2024-02-12 that the complaint#(b)(4) (mfg report number 8010762-2023-00610) device: cardiohelp is the same event as the complaint# (b)(4) (mfg report number 8010762-2024-00072) device: avalon cannula.The customer confirmed that the cardiohelp console has been functioning properly.The patient expired due to exsanguination.A getinge field service technician (fst) was sent for investigation on 2023-12-10/12.No part was replaced as no mechanical failure could be verified.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A medical review was performed by getinge medical affairs on 2024-02-29 with following conclusion: "the data retrieved from the service and user pools of the cardiohelp console indicate that the console operated according to expectations.Corresponding to the pool data, at 04:04:203 an arterial bubble triggered a high priority alarm, leading to a pump stop.Subsequently, the emergency mode was initiated by the customer at 04:08:21.Based on the timelines provided by the customer, it is assumed that there was a time setting misalignment of cardiohelp within its system settings.Therefore, all time stamps in the log files are likely to be recorded 2 hours later than the actual incident occurred.It is assumed that the emergency mode was activated during support to restart the pump, after a bubble detection resulted in a pump stop due to an activated intervention.According to the instruction for use (ifu), the activation of the emergency mode disables all alarms and interventions.This suggests that the pump operated in emergency mode from 04:08:21 onwards.In chapter 6.4.2 of the ifu a detailed instruction regarding resetting of the bubble alarm is provided.As a point of clarification, the complaint narrative does not specify whether the circuit was confirmed to be free of air/bubbles during the incident.However, upon the arrival of the perfusionist, air bubbles were observed only in the cannula.Therefore, it can be postulated that, at the time of the incident, air may have been present in the circuit which was detected by the flow/bubble sensor, resulting in a pump stop due to an activated intervention.By restarting the pump with the emergency mode, air bubbles may have been transported through the arterial/return line and not have been visible.According to the customer¿s answer to the questionnaire, a disconnection occurred at the return site of the avalon canula.A rapid blood loss due to an arterial line disconnection may allow air to enter the vascular system due to the venous suction, which was reported as -130mmhg at/close to the time of the event.It would be difficult to determine the amount of air entrained into the circuit under such circumstances.Regardless, the arterial flow-bubble sensor activated, stopping the pump due the active intervention.As no venous alarm was logged by the console, the optional venous bubble sensor of the cardiohelp does not appear to have been in use at the time of the event.Taking the response of the customer to question 4 in consideration (¿the cardiohelp console appeared to have been functioning properly¿), the cardiohelp performed according to specification and to the settings entered on site by the customer (as assumed via the available user and service pool data).According to the complaint narrative, exsanguination of the patient may have been related to a disconnection at the canula.Based on the data retrieved from the service and user pools and the report from the local getinge service technician, the available evidence suggests that the cardiohelp console functioned as expected and designed, without diminution in performance or expected behavior.Therefore, an association between the behavior and/or performance of the cardiohelp console (product), the outcome of the patient, and the cited event cannot be established." the device was manufactured on 2023-01-05.The device history record (dhr) of the cardiohelp was reviewed on 2023-12-08.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "mechanical failure on cardiohelp" could not 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 of the cardiohelp device.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).

Manufacturer Narrative

New information received on 2024-02-12 that the complaint# (b)(4) (mfg report number 8010762-2023-00610) device: cardiohelp is the same event as the complaint# (b)(4) (mfg report number 8010762-2024-00072) device: avalon cannula.The customer confirmed that the cardiohelp console has been functioning properly.The device was manufactured on 2023-01-05.The device history record (dhr) of the cardiohelp was reviewed on 2023-12-08.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (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: 18292021
• MDR Text Key: 330054687
• Report Number: 3008355164-2023-00044
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2024
• Distributor Facility Aware Date: 02/29/2024
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 02/29/2024
• Supplement Dates FDA Received: 12/15/2023; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death