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

Model Number HLS SET ADVANCED

Device Problems Decrease in Pressure (1490); Infusion or Flow Problem (2964)

Patient Problem Exsanguination (1841)

Event Date 12/08/2022

Event Type  Death  

Event Description

Initially it was reported that a patient on a cardiohelp required some trips to ct, was hand cranked (suspected triggering of zero-flow mode) and the cardiohelp as well as the hls set were exchanged.The patient was placed on ecmo on (b)(6) 2022 and stayed on this console until (b)(6) 2022.The customer pulled the run information of the cardiohelp and noticed that it was not recording any information for a couple of hours.The recording seems to stop after the unit was unplugged from the electrical outlet.No harm to any person has been reported.(factory reported as a product problem).Afterwards the information was received on 2023-01-05, that the cardiohelp was exchanged during treatment as the hospital staff did not mentioned that the zero flow mode was activated and interpreted this as an error from the cardiohelp device.Later they recognized that the zero flow mode was activated and the cardiohelp had no error.The hls set was exchanged as the delta pressure increased and the flow to the patient decreased.An hour prior to the circuit changeout, an infusion cannula was added due to a disintegrating femoral infusion graft.The circuit was clamped out briefly during the infusion site switchover and no heparin was given as the patient was massively exsanguinating.The hls set is not available for investigation.The patient expired.( now reporting as importer).Complaint id# (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.Note: the affected cardiohelp device will be investigated under (b)(4) (mfg report number 8010762-2022-00519).Hls set is not available for investigation, discarded.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that a patient on a cardiohelp required some trips to ct, was hand cranked (suspected triggering of zero-flow mode) and the cardiohelp as well as the hls set were exchanged.The patient was placed on ecmo on (b)(6) 2022.And stayed on this device until (b)(6) 2022.The patient was placed on the device due to a cardiogenic shock with extensive myocardial infarction and to place 4 stents during operation.The customer pulled the run information of the cardiohelp and noticed that it was not recording any information for a couple of hours.The recording seems to stop after the unit was unplugged from the electrical outlet.Afterwards the information was received on (b)(6) 2023, that the cardiohelp was exchanged during treatment as the hospital staff did not mentioned that the zero flow mode was activated and interpreted this as an error from the cardiohelp device.Later they recognized that the zero flow mode was activated and the cardiohelp had no error.The hls set was exchanged as the delta pressure increased and the flow to the patient decreased.No heparin was given as the patient was massively exsanguinating.The patient expired.The affected hls set is not available for investigation.The customer discarded the product as he did not believe the hls set to be the root cause of the event.The cardiohelp device will be investigated in complaint# (b)(4) (mfg report number 8010762-2022-00519).A medical review was performed by getinge medical affairs on (b)(6) 2023 with following conclusion: based on the customer information the root cause of the event strongly suggests a zero-flow state occurred during treatment as a result of backflow during treatment.An use error occurred when the zero flow state high priority alarm was not visualized and responded to correctly.As opposed to deactivating the zero flow mode and subsequently increasing the pump motor speed to achieve a positive flow state, hand cranking was initiated.The user error was confirmed by the customer.The patients clinical presentation was generally associated with significant morbidity and mortality.The failure of the data recording function is not associated with essential performance and therefore not associated with the patient outcome.Based on the review there was no malfunction or mal-performance of the cardiohelp console or the hls module.An internal debriefing of the medical staff occurred on site.Remedial training on awareness of this event and the mechanism was completed.The production records of the affected beq-hls 7050-ca #shls set advanced 7.0 were reviewed on 2023-03-24.According to the final test results, the hls set passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "zero flow mode, with pressure reading issues" could be confirmed, but was not device related.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.Hls set was discarded by 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: 16120523
• MDR Text Key: 306889367
• Report Number: 3008355164-2023-00003
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/I
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2023
• Distributor Facility Aware Date: 03/20/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death