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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050-CA #SHLS SET ADVANCED 7.0
Device Problems Decrease in Pressure (1490); Infusion or Flow Problem (2964)
Patient Problems Exsanguination (1841); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
Event Type  Death  
Event Description
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.Complaint id# (b)(4).
 
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
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 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.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.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.A follow-up medwatch will be submitted when additional information becomes available.Note: the affected cardiohelp device will be investigated under complaint# (b)(4) (mfg report number 8010762-2022-00519).H3 other text : 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 on (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 2023-03-20 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.H3 other text: hls set was discarded by customer.
 
Event Description
Complaint id: (b)(4).
 
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Brand Name
TUBING SET
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key16041758
MDR Text Key307772902
Report Number8010762-2022-00521
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112360
Number of Events Reported1
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 03/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2023
Device Model NumberBEQ-HLS 7050-CA #SHLS SET ADVANCED 7.0
Device Catalogue Number701069065
Device Lot Number3000242983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/18/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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