MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The event occurred in the us.It was reported by the customer that a patient was on cardiohelp-i and impella.Perfusion went to reconnect the waterlines to the hls set and the customer think they decoupled the disposable from the drive.The cardiohelp-i displayed the error message "disposable error: stop".The perfusionist was unable to restart flow on the pump.Patient began to code.They switched out both (the cardiohelp-i and the disposable) and went back on support.The patient expired the next day.The hospital tested both (the original cardiohelp-i and the hls set) the next day and had no problem establishing flow.Unfortunately, the customer did not save the disposable so it will not be returned.The involved cardiohelp-i will be handle in complaint ot (b)(4).Complaint id:(b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported by the customer that a patient was on cardiohelp-i and impella.Perfusion went to reconnect the waterlines to the hls set and the customer think they decoupled the disposable from the drive.The cardiohelp-i displayed the error message "disposable error: stop".The perfusionist was unable to restart flow on the pump.Patient began to code.They switched out both (the cardiohelp-i and the hls set) and went back on support.The patient expired the next day.The hospital tested both (the original cardiohelp-i and the hls set) the next day and had no problem establishing flow.Unfortunately, the customer did not save the disposable so it will not be returned.The involved cardiohelp-i will be handle in complaint (b)(4).The affected beq-hls 7050 usa #shls set advanced 7.0 with lot# 3000199071 was requested for investigation.But the requested product was scrapped therefore, a technical investigation could not be performed at the getinge laboratory.The reported failure and the application method described by the customer was evaluated by getinge medical affairs on (b)(6) 2022 with the following outcome: based on the available correspondence and the customer product complaint single reports (ot#(b)(4)) it appears the disposable de-coupled from the cardiohelp drive interface during the therapy.The system behavior described is consistent with the high priority alarm and the message reported by the clinician at the time of the event.A review of the log files would corroborate the error message reported.The disposable was not retained for further analyses.The hospital performed a functional assessment of the cardiohelp and the disposable the following day.No decrease in performance and/or malfunction was identified.There were no reported functional deficiencies during set-up, priming, and application until the reported event.Based on the proposed root cause, the event may be associated with multiple use errors.During set-up and application, the disposable may not have been properly secured in the hardware drive interface.The drive may have also been displaced from the drive interface during transport or during manipulation of the water lines as described in the complaint.A design mitigation includes a cardiohelp emergency drive to resume flow in the event of a pump stop for all causes.The immediate use of the drive was not reported and the review could not determine whether it was deployed.Based on the information available at this time the cause of the reported failure could be confirmed but was not be attributed to a device related malfunction.The device history review (dhr) records were reviewed on 2022-11-02 and according to the final test results, the beq-015703112 #shls module advanced adul with packaging lot#3000195935 and lot#3000195939 passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-660 v04 us.Chapter4.3.1 safety instructions for the oxygenator.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• 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: 15217177
• MDR Text Key: 297782087
• Report Number: 3008355164-2022-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• 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: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000199071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2022
• Distributor Facility Aware Date: 10/31/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death