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 Problem Insufficient Information (4580)

Event Date 12/19/2022

Event Type  Death  

Event Description

Initially it was reported that there was a pressure drop without any flow restrictions.No harm to any person has been reported.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).Complaint id# (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.H3 other text: hls set was discarded by the customer.

Event Description

Complaint# (b)(4).

• 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: 16137093
• MDR Text Key: 307076527
• Report Number: 3008355164-2023-00005
• 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: Distributor
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2023
• Distributor Facility Aware Date: 04/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2023
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death