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

Model Number CARDIOHELP-I

Device Problems Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2022

Event Type  Death  

Event Description

Customer reported a defective atrial bubble sensor while patient was on ecmo.The atrial bubble sensor alarm was triggered which stopped the flow.The lines were then clamped and the dearing protocol was performed.Then the venous bubble alarm was triggered with no visible bubble and was reset.Estimated time of ecmo flow interruption was about 1-2 minutes.The patient expired.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.So far the cardiohelp was inspected and it works fine with no error messages.Also the flow bubble sensor was inspected and it works fine and is not defective.Further information has been requested but has not yet been received.A medical review was requested and a follow-up emdr will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that one venous bubble alarm and two arterial bubble alarms were triggered without any visible air bubbles.The event occurred during treatment.No intervention was set for the redundant venous bubble sensor.The intervention of the mandatory arterial air bubble sensor triggered the pump stop twice as per design to prevent complications of air embolism.After each pump stop the customer manually clamped the lines, aspirated from the pre oxygenator pigtail and inspected the circuit for air.No air was seen on aspiration.The treatment was continues about 1 minute and 46 seconds after the first pump stop.The patient did die many days later, according to the customer this was not at all related to this incident.The clinic did not elaborate on the cause of death.A getinge field service technician (fst) was sent for investigation on 2022-10-27.The cardiohelp and both the venous and the arterial bubble sensors were tested and no device malfunction was identified during the service.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.According to the log file review performed by getinge life cycle engineering for the reported date of event 2022-10-23 at 17:48:37 (cardiohelp time), the venous bubble was detected 3 seconds before the first arterial bubble alarm was logged at 17:48:37.No intervention was set by the user for the venous bubble monitoring, therefore only the arterial bubble detection stopped the pump.The operator reset at 17:49:49 the arterial bubble intervention leading to a pump start (downtime.1 min 12 sec) shortly afterwards (2 sec) a second arterial bubble alarm was logged with a downtime of 34 sec.In two triggered pump stops there was in total no flow for 1 minute and 46 seconds (1 min 12 sec and 34 sec downtime).A medical review was performed by getinge medical affairs on 2022-12-05 with the following conclusion: the review of the patient outcome and any association with this sequence of events is challenging given there is a paucity of clinical information.However, a review of the customer product complaint single report, follow-up correspondence, service report, and logs files provide reasonable insight into the most likely root cause of the event reported based on the available information.The most likely root cause of sequential air bubble alarms on both venous bubble sensor and arterial flow bubble sensor appears to be related to the administration of albumin via the central line during therapy.As described in the evaluation, a rapid change in the nature of the fluid transiting the acoustic window in an ultrasonic bubble sensor can trigger a false positive bubble.The log file alarms and the reported concurrent administration of albumin support this mechanism.The service report indicated the system and bubble sensors were functioning to specification.The clinician reported no air was visualized during the de-airing protocol.In sum, this supports the conclusion this occurrence was a ¿false positive alarm¿ triggered by the above mechanism.The safety system intervention and the observed occurrence are known limits of the technology and sensitivity of ultrasonic sensors.The transmission of air into the circuit by any means is always possible but the available information does not support this conclusion given the description provided by the end user.Although the patient outcome is very unfortunate, based on the available information and associated self-reporting by the clinic, no association between the patient outcome and this sequence of events can be suggested.The cardiohelp device and safety systems functioned within specification.The false positive alarm proposed is a known limitation of state of the art technology.A determination of whether a use error occurred is challenging.Rapid administration of fluids (colloids/crystalloids) is a common and necessary clinical intervention for patients undergoing extracorporeal support.False positive alarms can occur based on the limitations of the technology as described above.It appears that the event was expertly managed by the clinician and is consistent with best practice, training, and the device cautions and warnings in the instructions for use (gmbh, heart lung support system cardiohelp system instruction guidelines, 2022), (gmbh & maquet cardiopulmonary , hls cannulae set instructions for use |2.6 |g-139|05).

Event Description

It was reported that one venous bubble alarm and two arterial bubble alarms were triggered without any visible air bubbles.The event occurred during treatment.No intervention was set for the redundant venous bubble sensor.The intervention of the mandatory arterial air bubble sensor triggered the pump stop twice as per design to prevent complications of air embolism.After each pump stop the customer manually clamped the lines, aspirated from the pre oxygenator pigtail and inspected the circuit for air.No air was seen on aspiration.The treatment was continues about 1 minute and 46 seconds after the first pump stop.The patient did die many days later, according to the customer this was not at all related to this incident.The clinic did not elaborate on the cause of death.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: 15713900
• MDR Text Key: 302834151
• Report Number: 3008355164-2022-00028
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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: 12/13/2022
• Distributor Facility Aware Date: 11/16/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death