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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Fluid/Blood Leak (1250)
Patient Problem Anemia (1706)
Event Date 01/24/2022
Event Type  Injury  
Event Description
The following was reported: "this morning we had to do an emergency cardiohelp circuit change-out due to a break/leak in the circuit causing a copious amount of blood loss.Staff noticed blood leaking from underneath the circuit around 5:30 this morning after the patient started to complain about feeling short of breath.It was not obvious as to the exact point from where the circuit was leaking from as all the ports/pigtails were intact and dry.No obvious air was introduced into the system, leading us to believe the leak was somewhere between the centrifugal head and pre-oxy face where the disposable met the machine.The circuit was exchanged rather quickly (around 7 am) but the patient required transfusion of red cells and ffp due to blood loss during that short amount of time.It was estimated that at least two units of blood were lost from the circuit before exchange could be completed.This particular circuit was on the patient from (b)(6) 2022 till this morning, (b)(6).There were no issues leading up to the incident including the circuit being bumped.We have saved the circuit to be returned for investigation.Patient was negatively impacted due to transfusion requirement, fluid imbalance, inflammatory response due to new circuit, etc.Possibly delaying ecmo wean." complaint id: (b)(4).
 
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
Fields in section b and h were corrected from product problem / malfunction to adverse event & product problem / serious injury.
 
Manufacturer Narrative
The following was reported: "this morning we had to do an emergency cardiohelp circuit change-out due to a break/leak in the circuit causing a copious amount of blood loss.Staff noticed blood leaking from underneath the circuit around 5:30 this morning after the patient started to complain about feeling short of breath.It was not obvious as to the exact point from where the circuit was leaking from as all the ports/pigtails were intact and dry.No obvious air was introduced into the system, leading us to believe the leak was somewhere between the centrifugal head and pre-oxy face where the disposable met the machine.The circuit was exchanged rather quickly (around 7 am) but the patient required transfusion of red cells and ffp due to blood loss during that short amount of time.It was estimated that at least two units of blood were lost from the circuit before exchange could be completed.This particular circuit was on the patient from (b)(6) 2022 till this morning, 1/24.There were no issues leading up to the incident including the circuit being bumped.Patient was negatively impacted due to transfusion requirement, fluid imbalance, inflammatory response due to new circuit, etc.Possibly delaying ecmo wean." the returned product was technically investigated at the laboratory of the manufacturer.Visual inspection of the complaint sample showed blood contamination outside of the product, below the pump cover.Furthermore, a blood filled venting port on the venting membrane could be detected during the visual inspection.The subsequent leak test showed a leak at the gas outlet of the oxygenator, which cannot be linked locally to the blood contamination found in the visual inspection.The customer reports a blood leak below the loop, which suggests that the leak from the gas outlet was already present at the customer.In order to reproduce a possible liquid leakage of the ventilation membrane and thus to confirm the visual inspection, the leak test was repeated with the gas outlet disconnected.This resulted in a severe leak at the vent membrane, which confirms the visual inspection and explains the blood contamination on the pump cover.Thus the reported failure "leaking from underneath the circuit" was confirmed.The most probable causes of the two different failures detected were determined as follows: leaking ventilation membrane: damages to the ventilation membrane.Inadequate welding of the vent membrane to the vent connector.Inadequate bonding of the vent connector into the blood outlet cover plate.Leaking gas outlet port: insufficient pur (polyurethane) grouting of mat pack.This allows the fluid to transfer to the outer cover.Fiber detachment in the pur potting.This allows the fluid to leak between the fiber an the pur encapsulation.Fiber damage this allows fluid to leak trough the oxygenating fiber.The root cause investigation of the manufacturer is still ongoing.
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The affected product was further investigated at the laboratory of the manufacturer.The subsequent leak test showed a leak at the gas outlet of the oxygenator, which cannot be linked locally to the blood contamination found in the visual inspection.The customer reports a blood leak below the loop, which suggests that the leak from the gas outlet was already present at the customer.The outer cover plates of the product were opened.Hereby it was determined that the leckage was attributed to two fibers within the gas mat packet.The leackage was caused by fiber damage.In order to reproduce a possible liquid leakage of the ventilation membrane and thus to confirm the visual inspection, the leak test was repeated with the gas outlet disconnected.This resulted in a severe leak at the vent membrane, which confirms the visual inspection and explains the blood contamination on the pump cover.Thus the reported failure "leaking from underneath the circuit" was confirmed.The most probable causes of the two different failures detected were determined as follows: leaking ventilation membrane: damages to the ventilation membrane.Inadequate welding of the vent membrane to the vent connector.Inadequate bonding of the vent connector into the blood outlet cover plate.Leaking gas outlet port: fiber damage: this allows fluid to leak trough the oxygenating fiber.Furthermore a medical assessment of the event description and investigation results was performed.It was concluded that the actual mechanism of the damage the two blood fibers and the more general finding of damage to the gas mat package was not determined.A review of the investigation reports suggests but does not confirm the findings may be associated with a manufacturing root cause.Maquet cardiopulmonary initiated a non-conformance process in regards to the detected findings.All further actions and investigations will be performed within this process.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.
 
Event Description
Complaint id: (b)(4).
 
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Brand Name
HLS SET ADVANCED
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
neue rottenburger strasse 37
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MDR Report Key13357250
MDR Text Key284443436
Report Number8010762-2022-00022
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2022
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701052794
Device Lot Number3000174227
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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