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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#HLS SET ADVANCED 7.0
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
The event occurred in the us.It was reported that a patient was on cardiohelp-i with vv support on (b)(6) 2021 due to complications with covid.Everything was going fine until (b)(6) 2021 when the hls module started to clot off.They swapped out the previous hls set for a new hls set on this date.Patient is stable at this time.It was stated by the customer that the patient was covid positive and they felt that this was as issue related to that condition.The customer discarded the circuit previously.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.The increased risk of thrombosis and coagulopathy in ecmo patients is a result of a combination of processes driven by the disease occurring in synergy with the effect of the extracorporeal circuit on the coagulation system.With reference to the risk assessment hls set advanced 5.0 / hls set advanced 7.0, dms#(b)(4), v26 and in consultation with the manager medical affairs the following events can contribute to clotting in the circuit: air remains in or enters the circuit, hemostasis, air or blood remains in luer lock access port , too low anticoagulation, too low at level, effect of heparin is too limited, protamine sulfate enters the hls set, administration of substitution of congealable substance such as plateles, (consumption) coagulopathy, thrombocytopenia.Based on this results the reported failure hls module clotted off could be confirmed.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 cardiopulmonarys trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
The event occurred in the us.It was reported that a patient was on cardiohelp-i with vv support on (b)(6) 2021 due to complications with covid.Everything was going fine until (b)(6) 2021 when the hls module started to clot off.They swapped out the previous hls set for a new hls set on this date.This event will be handle in this complaint (b)(4).Over those two weeks the internal pressure numbers stared to be very erratic, increasing rapidly and then decreasing rapidly.On (b)(6) 2021 the hls started to display very high internal pressure numbers (900's) again and then would drop down to 300's.Customer made the decision to swap out this hls set as he needed reliable pressure numbers and felt this hls module was not "working correctly".Patient is stable at this time.This internal pressure issue will be handle in complaint (b)(4).No indication of actual or potential for harm or death has been reported.This is the first complaint to this event - related with complaint ot (b)(4) "internal pressure failure".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
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MDR Report Key11911989
MDR Text Key253458685
Report Number8010762-2021-00308
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age43 YR
Patient Weight94
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