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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problems Pumping Stopped (1503); No Flow (2991)

Patient Problem Cardiac Arrest (1762)

Event Date 05/12/2022

Event Type  Injury  

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

It was reported that the pump stopped and there was no flow.The patient suffered from oxygen deprivation (hypovolemia) during treatment.This complaint is associated to another complaint for hardware device cardiohelp complaint# (b)(4).Complaint id:(b)(4).

Manufacturer Narrative

This complaint is associated to another complaint for hardware device cardiohelp complaint# (b)(4) which was reported under mfr#8010762-2022-00178 on 2022-05-18.It has been reported that there was no flow and the patient suffered from oxygen deprivation (hypovolemia) during treatment.The hls set was exchanged during patient treatment.The affected hls set was technical investigated at the getinge laboratory on 2022-07-05.During the visual inspection no damage or abnormalities could be detected.Further no clots or tissue residuals could be identified which can cause potential changes in flow behavior of the centrifugal pump.The complaint sample does not show any irregularity in flow behavior.Pressure values and flow values are in common range.The additional performed functional test with water shows constant flow over the complete testing period without deviations.Based on the performed tests it can be stated that the function of the centrifugal pump of the complaint sample is given.The reported failure was not reproducible during the technical investigation, no product related malfunction could be detected.The production records of the affected be-hls 7050 #shls set advanced 7.0 with packaging lot#3000188598 were reviewed on 2022-07-08.According to the final test results, the hls set with lot#3000188598 and (b)(6) passed the tests as per specifications.Production related influences are unlikely.The root cause investigation of the manufacturer is still ongoing.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It has been reported that there was no flow and the patient suffered from oxygen deprivation (hypovolemia) during treatment.The hls set was exchanged during patient treatment.There is an associated complaint for hardware device cardiohelp, complaint #(b)(4).Reported under mfg 8010762-2022-00178.The affected hls set was technical investigated at the getinge laboratory on 2022-07-05.During the visual inspection no damage or abnormalities could be detected.Further no clots or tissue residuals could be identified which can cause potential changes in flow behavior of the centrifugal pump.The complaint sample does not show any irregularity in flow behavior.Pressure values and flow values are in common range.The additional performed functional test with water shows constant flow over the complete testing period without deviations.Based on the performed tests it can be stated that the function of the centrifugal pump of the complaint sample is given.The reported failure was not reproducible during the technical investigation, no product related malfunction could be detected.A medical review was performed by getinge medical affairs with the following outcome: the customer describes hypovolemia as the cause of the cardiac arrest.The decreased volume status results in a reduced preload.Since centrifugal pumps are preload dependent, a too low preload can cause flow problems even though the pump is running.An increasing negative venous pressure could have been an indicator for this situation.Even if no information on the pressures was obtained, the collapsed venous line indicates the reduced venous drainage.As stated by the customer the hypovolemia was caused by liver bleeding.After administering volume to the patient flow could be achieved.It is possible that this could be achieved by the increased preload due to the administered volume.Further possible root cause may have also contributed to the insufficient drainage and, therefore, no/inadequate flow: it could also have been the case that there was a translocation of the volume in the patient´s body and that the manipulations during cpr or a change in the patient's position had improved the volume status and thus the flow.If the cannula position was a factor, this could also have changed positively because of the manipulations during cpr or a change in the patient´s position and resulted in an increased flow.The customer stated in the complaint report that there was an abrupt pump stop.Based on the customer's statement that hypovolemia could be confirmed by patient observation and taking into consideration that flow could be generated later on without changing anything in the system, it appears that hypovolemia was the likely root cause of the event.Additionally, the circumstance that administering volume to the patient resulted in increased flow underlines the conclusion that the patient¿s volume status was the root cause for the prescribed situation.The result of the investigation report that the function of the centrifugal pump is intact, supports this assessment.No malfunction of the system could be determined in the investigation report and therefore no link between the event and the system could be discovered.Further, given the available information, there is no indication of an association between the product and the event experienced by the patient.The production records of the affected be-hls 7050 #shls set advanced 7.0 with packaging lot #3000188598 were reviewed on 2022-07-08.According to the final test results, the hls set with lot #3000188598 and udi #(b)(4) passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "no flow and the patient suffered from oxygen deprivation" could be confirmed, but was not related to a product malfunction.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14495687
• MDR Text Key: 292590260
• Report Number: 3008355164-2022-00015
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000199084
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2022
• Distributor Facility Aware Date: 07/14/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2022
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 80 KG