MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ HLS 7050 USA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Cardiac Arrest (1762)

Event Date 07/15/2022

Event Type  Death  

Manufacturer Narrative

Hls set was thrown away.

Event Description

It was reported that the unit was giving an error message that the arterial and venous temperature is out of range.The failure occurred during treatment.All other functions appeared to be normal.The patient died on (b)(6) 2022 but per customer the hls set and the cardiohelp were functioning correctly, except for the temperature.The patient was operated and was unable to come off the bypass and arrested.The patient was resuscitated and than placed on the cardiohelp, but never recovered.The hls set is not available for investigation as it was thrown away by the customer.The cardiohelp will be handled under complaint# (b)(4).Complaint id (b)(4).

Manufacturer Narrative

It was reported that the unit was giving an error message that the arterial and venous temperature is out of range.The failure occurred during treatment.All other functions appeared to be normal.The patient died on (b)(6) 2022 but per customer the hls set and the cardiohelp were functioning correctly, except for the temperature.The patient was operated and was unable to come off the bypass and arrested.The patient was resuscitated and than placed on the cardiohelp, but never recovered.The hls set is not available for investigation as it was thrown away by the customer.The adverse event was investigated by getinge medical affairs on 2022-10-18 with following conclusion: " the evaluation of the existing details lead to the conclusion that beside the temperature measurement, the hls module most likely had no malfunction and did not contribute to any harm of the patient.The customer stated that the patients temp was 37.5°c, measured by external source (nasopharyngeal probe).Further, the customer stated that the cardiohelp and the included hls module were not contributory to the expiration of the patient.While no temperatures were displayed on the cardiohelp unit, the patient had a nasopharyngeal temperature probe.Further, a bair huggertm (a noninvasive warm air external heater) as well as the ecmo circuit heater were both set to 36.5 degrees.According to the instruction for use (hls set advanced 5.0 / 7.0, hit set advanced5.0 / 7.0, g-660, version 04 · us) in chapter 4.3.1 safety instructions for the heat exchanger the following is stated: test the functioning of the temperature sensors before each use.Only use tested and approved temperature sensors.The arterial and venous sensor have separate power supply cable and data stream, as well as measurement position and technique; therefore, it is unlikely that both alarms (arterial and venous) were present at the same time.It is assumed that either one or the other temperature parameter was out of range give differing methods of gather the venous versus the arterial temperature (viz.Via the venous temperature probe versus the integrated arterial sensor on the hls disposable, respectively).The definite root cause cannot be defined due to lack of information and as the disposable (hls set) has been discarded and is not available for investigation by getinge.Possible root causes for the reported alarm message ¿temp out of range¿ could be the following: the temperature was above 45°c or below 10°c which is unlikely, because of the measured 37.5°c, measured by external source by the nasopharyngeal probe.The sensor cable could have been defective and producing invalid data.This possibility is unlikely as the sensor creates a digital signal and no signal would be provided if a defect were present.) it is also possible that the sensors in the hls module could have been defective.That said, it is unclear why both, the arterial and venous temperature were reported to be out of range, as both are in different positions and measure with different methods.Additionally, both sensors have separated power and data stream, and are, therefore, functioning in an isolated manner.Based on the customer narrative it is assumed that the clinical morbidities of the patient led to the expiration of the patient and, therefore, were not associated with either the cardiohelp and hls set." checking the manufacturers instruction for use (ifu), (ifu cardiohelp system, chapter 9 messages), which states if the measured values are above high limit or below low limit of the set limits and if the sensor is defective the system generates a visual and acoustical alarm.To monitor the patient temperature the venous temperature is measured by the venous probe.Further in case of a failing arterial temperature sensor an external sensor can be connected (ifu , chapter 5.3.3 connecting external temperature sensors).The production records of the affected beq-hls 7050 usa #shls set advanced 7.0 were reviewed on 2022-09-30 for the reported failure.According to the final test results, all hls set advanced 7.0 passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "arterial and venous temperature out of range" could not be confirmed or reproduced and an exact root cause could not be determined.Based on the customer narrative it is assumed that the clinical morbidities of the patient led to the expiration of the patient and, therefore, were not associated with either the cardiohelp and hls set.The customer will be informed about the results by the getinge sales and service unit.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.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.Note: the affected cardiohelp will be investigated under complaint# (b)(4) (mfg report number # 8010762-2022-00280).H3 other text : ls set was discarded by customer.

Event Description

Complaint id # (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, 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: 15065334
• MDR Text Key: 296228276
• Report Number: 3008355164-2022-00020
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: BEQ HLS 7050 USA
• Device Catalogue Number: 701069078
• Device Lot Number: 3000196195
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2022
• Distributor Facility Aware Date: 10/18/2022
• Device Age: 1 YR
• Date Report to Manufacturer: 10/20/2022
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male