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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2023

Event Type  Death  

Event Description

It was reported that the venous probe would not read the oxygen saturation (svo2).The failure occurred during treatment.There was no adverse effect to the patient from the reported cardiohelp complaint as stated by the getinge field service technician (fst), but the patient expired while on the cardiohelp device.Complaint id (b)(4).

Manufacturer Narrative

A getinge field service technician (fst) was sent for investigation on 2023-03-07.The fst could not verify the reported failure.The venous probe with 4 lenses and the cable passed the physical inspection and the teaching sequence, as well as the self-test.Considered to the event he venous probe and its cable were replaced as a precaution.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The fst further analysed the log files of the cardiohelp and could not confirm any adverse events or errors.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 venous probe would not read the oxygen saturation (svo2).The failure occurred during treatment.There was no adverse effect to the patient caused by the reported cardiohelp complaint as stated by the getinge field service technician (fst), but the patient expired while on the cardiohelp device.A getinge field service technician (fst) was sent for investigation on 2023-03-07.The fst could not verify the reported failure.The venous probe with 4 lenses and the cable passed the physical inspection and the teaching sequence, as well as the self-test.Considered to the event the venous probe and its cable were replaced as a precaution.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Furthermore the fst performed a logfile analysis and there were no adverse events or errors included.The affected venous probe and venous probe cable were investigated by getinge life-cycle-engineering on 2023-05-10.The failure was not reproducible, nor did the logfiles show any error in regard to the venous probe.The most probable root cause could be determined as a not correctly seated venous probe to the hls-set and that this was the reason for the erroneous measurements.Furthermore.A medical review was performed by getinge medical affairs on 2023-05-17 with following conclusion: " the examinations of the venous probe, the associated cable and the console have not revealed any malfunctions.It is necessary to initialize the venous probe before use to receive useable results.In addition to the initialization, it is also important to connect the venous probe correctly to the measure point on the hls set.If the seat of the venous probe is improper, the measured values might be incorrect.In principle, the values indicated by the venous probe (svo2, hb, hct, tven) have to be checked regularly and calibrated by means of blood gas analysis.Therapeutic measures must not be taken on the basis of the values measured by the venous probe.For this purpose, a blood gas analysis has to be performed.According to the getinge service and sales technician there are no adverse events or errors included in the logs.All equipment¿s passed the inspection and the venous probe passed the teaching sequence.Furthermore the venous probe and its cable were replaced out of precaution.There was no adverse effect to the patient from the reported cardiohelp complaint, but the patient expired during the treatment on the cardiohelp out of unknown circumstances.In summary, it can be stated that the cause of the error is not likely attributable to the product." the venous probe does not influence the blood flow of the device.The venous probe is for monitoring the blood gas values (hemoglobin (hb), hematocrit (hct), oxygen saturation (svo2) and venous temperature).In the instructions for use (ifu), chapter 2.2.5 "monitoring and sensors" of the cardiohelp system it is stated that these values must be regularly checked by the user via a blood gas analysis by a laboratory.Furthermore, in the ifu is stated that prior to a therapeutic measure based on the parameters displayed a laboratory blood gas analysis must be checked.The cardiohelp generates an acoustic and visible alarm in case of a failure of the venous probe.Additionally in the ifu chapter 5.1 "application overview for disposables" is stated that if the disposable was changed during operation the venous probe should be re-initialized again.The review of the non-conformities has been performed on 2023-02-28 for the period of 2020-04-24 to 2023-02-27.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 2020-04-24.Based on the results the reported failure "venous probe wrong saturation measurement" 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.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: 16527558
• MDR Text Key: 311121283
• Report Number: 8010762-2023-00132
• 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
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• 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: 701072780
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death