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 Increase in Pressure (1491)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.The affected hls set has been requested for further investigation in the getinge laboratory but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.The getinge service and sales unit reported on (b)(6) 2021 that the patient deceased in relation to the illness severity and not in relation to a product malfunction.Further information has been requested but is pending.The investigation is ongoing.

Event Description

The event occurred in the (b)(6).It was reported that same patient as in complaint lot 442889 was involved in the event but hls module has a another lot#.The patient was transferred to (b)(6).The perfusionist stated that there was suddenly a delta p increase to 110.Flow went down 300ml when this happened.After 45 minutes delta p went down again from 110 to 75 and flow went back to normal.Pao2 was good, pco2 was good, po2 was good, no clothes where seen in the oxy.They decided to not exchange the oxygenator.In total this happened 3-4 times in 3 days time.In the night from tuesday to wednesday the flow went down again, max 3,8l with more rpm¿s.The intensivist and the perfusionist decided to not change the oxygenator because the patient was not recovering and they were going to stop the treatment anyway.No indication of actual or potential for harm or death has been reported.New information provided by the (b)(6) on (b)(6) 2021 that the patient expired.Complaint id: (b)(4).

Event Description

Complaint: (b)(4).

Manufacturer Narrative

The event occurred in the netherlands.The same patient was involved as in complaint ot 442889 (it 2045162).The patient was transferred to erasmus mc, rotterdam.The perfusionist stated that there was suddenly the delta p pressure increase to 110 mmhg.Flow went down to 300ml when this happened.After 45 minutes delta p pressure went down again from 110 mmhg to 75 mmhg and flow went back to normal.Pao2 was good, pco2 was good, po2 was good, no clothes were seen in the oxygenator.Customer decided to not exchange the oxygenator.In total this happened 3-4 times in 3 days.In the night from tuesday to wednesday the flow went down again, max 3,8l with more rpm¿s (rounds per minutes).The intensivist and the perfusionist decided to not change the oxygenator because the patient was not recovering and they were going to stop the treatment anyway.No indication of actual or potential for harm or death reported has been reported at this time.The getinge sales and service unit informed on (b)(6) 2021 that the patient expired on (b)(6) 2021 in relation to illness severity, not related to the used hls set.The affected hls set was investigated in the getinge laboratory on (b)(6) 2021 and no abnormalities on the hls module were detected, the sensor system of the product was also functional.The reported failure could not be confirmed.For further investigation patient data was collected and a medical review was performed by getinge medical affairs specialist on (b)(6) 2021: based on the available information the event observed by the customer was neither caused by a defect in the product nor the product itself.The product investigation could not reproduce the observation reported by the customer.The most probable root cause of the expiration of the patient likely arose from the poor clinical constitution of the patient in addition to possibly unmentioned comorbidities.According to the details provided by the customer, it was noticed that the aptt (partial thromboplastin time) during support was lower than recommended for ecmo (i.E.60-80 seconds).The aptt on the day of the reported event was 23 and, several days later, was 53.This may be reflective of insufficient anticoagulation.The d-dimers markers are indicative of existing clot (i.E.> 0.50).On the day of the reported event, the d-dimers where a shade above normal, in the following days were significantly higher (~ 3 to 10x) than the recommended value of below 0.50.A low aptt may have contributed to the formation of clots.Based on this evaluation results a malfunction of the hls set could be excluded.The most probable root cause for the reported failure "delta p increased" could be determined as: the poor clinical constitution of the patient, insufficient anticoagulation.Device history record (dhr) review was performed on 2021-05-21 and there were no references found, which are indicating a non-conformance of the product in question.Following tests were performed on the hls module: pressure test heat exchanger, leak test water/gas side, pressure test blood side, final functional test : according to the final test results, all hls modules passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "delta p increased" could not 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.Cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12009048
• MDR Text Key: 256488909
• Report Number: 3008355164-2021-00018
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2021
• Distributor Facility Aware Date: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2021
• Date Manufacturer Received: 06/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death