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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6) during patient treatment.The customer reported a premature thrombosis of 2 hls set on the same patient.The hls set was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The customer reported a premature thrombosis of an hls set.The patient was infected with covid-19.The hls set was exchanged during patient treatment.The affected hls set was technically investigated in the getinge laboratory on 2022-07-01.During the investigation the reported failure could be confirmed.After flushing the module with water, a clot was found in the pump module, in the area of the rotor.Further, larger clots were flushed out during the cleaning process.The tests did not identify any clear technical causes of failure that could be directly related to clotting in the product.As possible causes, the application of the product on site and medication during use should be considered and checked by the clinical side.A medical assessment was performed by getinge medical affairs on 2022-08-16 with the following outcome: presumably based on the reported recovery and outcome, the original coagulopathy was corrected overtime.The patient may have had a spectrum of coagulopathic states from hypo-coagulable to hyper-coagulable during therapy.The clinical management was not described and therefore no potential root causes are proposed that could have resulted in a hypercoagulable state during extracorporeal circulation.Covid-19 has been associated with hypercoagulability and derangement of suggested coagulation metrics during extracorporeal circulation.Patients with coronavirus disease (covid-19) may have a number of complex and varied coagulation abnormalities that create a hypercoagulable state.A review of the investigated hls set by the manufacturer did not identify a root cause associated with the device complaint.The most probable root cause for the decrease in device performance is associated to thrombus accumulation in the device due to patient related factors.The production records of the affected hls set were reviewed on 2022-07-04.According to the final test results, the affected hls module with lot#3000194193 and udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "indication of premature thrombosis" could be confirmed but no product related malfunction could be determined.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.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The customer reported a premature thrombosis of an hls set.The hls set was exchanged during patient treatment.The affected hls set was technically investigated in the getinge laboratory on 2022-07-01.After flushing the module with water, a clot was found in the pump module, in the area of the rotor.Further, larger clots were flushed out during the cleaning process.The tests did not identify any clear technical causes of failure that could be directly related to clotting in the product.As possible causes, the application of the product on site and medication during use should be considered and checked by the clinical side.The most probable causes could not be determined during the technically investigation.Therefore a medical assessment was requested.The production records of the affected hls set were reviewed on 2022-07-04.According to the final test results, the affected hls module with lot#3000194193 and udi# (b)(4), passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "indication of premature thrombosis" could be confirmed but no product related malfunction could be determined.The root cause investigation of the manufacturer is still ongoing.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 13824005
• MDR Text Key: 287526518
• Report Number: 8010762-2022-00092
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000205877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 113 KG