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

Model Number HLS SET

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

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

Event Date 12/19/2022

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 there was a pressure drop without any flow restrictions.No harm to any person has been reported.Complaint id#: (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

The event occurred in germany during treatment.It was reported that there was a pressure drop without any flow restrictions 15-30 minutes after start of the treatment on the patient and the pressure within the oxygenator started to increase.The treatment with the cardiohelp device was terminated as the customer did not see any use in it anymore.A getinge field service technician (fst) was sent for investigation and repair and found no issue on the cardiohelp.Therefore the fst stated that the failure can be allocated to the hls set.On 2023-01-09 the information was received that the patient expired and the cardiohelp device did not influenced the death of the patient.The cardiohelp will be investigated in complaint# (b)(4) (mfg report number 8010762-2022-00522) and the complaint# (b)(4) will be changed from a cardiohelp complaint into a hls set complaint (mfg report number 8010762-2022-00525).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint# (b)(4).

Manufacturer Narrative

It was reported that there was a pressure drop without any flow restrictions a couple of minutes after the start of the treatment on the patient.Furthermore the pressure within the oxygenator started to increase (pint).Oxygenation and flow were present.The treatment with the cardiohelp device and hls set were terminated as the customer did not see any use in it anymore for the patient due to his diagnosis.The getinge field service technician (fst) confirmed that the treatment would have been canceled even if there was no pressure reading failure.There is no information about the lot or article number of the affected hls set.On 2023-01-09 the information was received that the patient expired and the devices did not influenced the death of the patient.A getinge field service technician (fst) was sent for investigation and repair and found no issue on the cardiohelp.Therefore the fst stated that the pressure failure can be allocated to the hls set.The cardiohelp device will be investigated in complaint# (b)(4) (mfg report number 8010762-2022-00522).On 2023-03-28 the information was received that the customer discarded the affected hls set by mistake.A medical review was performed by getinge medical affairs on 2023-04-05 with following conclusion: "the examination by the service technician of getinge did not reveal any abnormalities with the cardiohelp.From a technical point of view, the full functionality of the cardiohelp could be confirmed after performing all functional tests.The available information is limited to the statement in the complaint report that the internal pressure indicated approximately 500 mmhg ten minutes after the start of perfusion.Based on this data, the following root causes for this event could be feasible.These possible root causes may apply fully, partially, or not at all.- in principle, the pressure sensors must be calibrated before use.If the cardiohelp-i is switched off after the sensors have been calibrated and before the cardiohelp-i is used, the calibration previously performed will be forfeited.This could result in incorrectly measured pressures.However, an even greater offset could have been caused by calibrating the pressure sensors with liquid in the hls set advanced.If liquid is already in the hls set advanced and the user then calibrates the sensors without taking further action, an offset will occur due to the pressure from the water column that is present in the hls set advanced.- there is no data available regarding the rpm/flow settings.Too high flows can in general also result in increased pressures.- furthermore, it is not known whether only the internal pressure or also the arterial pressure has increased.An incorrectly positioned cannula or a fundamentally increased resistance of the patient, for example due to vasoconstriction, can cause increased system pressure.- no information on anticoagulation is available either.If the act (activated clotting time) and/or ptt (partial thromboplastin time) were too low, clotting may have occurred in the oxygenator, causing its resistance to increase and thus the internal pressure to rise.This would also increase the delta p (p internal ¿ p arterial = delta p).There is no data regarding the delta p available.There is no information regarding the expiration of the patient, but based on the aforementioned possible root causes, in addition to the report of the service technician, there is no indication that the cardiohelp was the source of the increasing internal pressure.Since the hls set was discarded by the customer, it was not possible to investigate the disposable.However, the possibility of wrong calibrated pressure sensors, clotting, increased patient resistance, or the incorrect placement of the arterial cannula are the most likely root causes of the event.The examination of the cardiohelp is in support of this determination as no malfunctions could be confirmed.The expiration of the patient appears to be due to reasons outside of the cardiohelp." furthermore, according to the risk assessment of the hls set advanced, hit set advanced ((b)(4), (b)(6)) the following root causes can lead to the reported failure: - wrong pressure measurement due to malfunction of the pressure sensor - blockage of oxygenator.Moreover, in the instruction for use of the involved disposables (hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, v2.3, chapter 7.1 preparation and installation and quadrox-ir small adult / adult, chapter 7.2 priming the system) it is stated that the pressure sensors have to be calibrated and checked before priming.Based on the results the reported failure "wrong pressure values" could not be confirmed as a product related 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.H3 other text : hls set was discarded by the customer.

• Brand Name: TUBING SET
• 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: 16042059
• MDR Text Key: 306694973
• Report Number: 8010762-2022-00525
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death