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

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

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  Death  

Manufacturer Narrative

The product and further information (patient data, perfusion protocol) was requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.Please note this case is connected to complaint#(b)(4) (second hls set involved) which will be reported under emdr#(b)(4).

Event Description

The customer reported that during priming no flow was achieved.While setting up of the circuit the patient expired.See detailed description provided by customer below: "(b)(6) ccp advised that she set up the cardiohelp console with serial number (b)(4) and set up a new hls circuit with lot number 70142667.She was able to zero the pressures and successfully prime the circuit via gravity.However she said when she set the rpms to 3000 there was no flow.She set the rpms to zero and removed the hls set from the pump drive without removing the pressure & temperature cable and returned the hls set to the pump drive.She set the rpms to 3000 and stated that.02 lpm showed on the screen thus there was no flow.She said that there was no positive or negative flow showing on the system.She stated that the hls system was removed from the primebag.They were unable to achieve any flow with this circuit.They isolated pump serial number (b)(4) and hls set with lot 70142667." please note this case is connected to complaint (b)(4) (second hls set involved) which will be reported under emdr#(b)(4).Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hls achieved no flow during priming.The device was not being used for treatment.The used cardiohelp is handled under complaint# (b)(4) (mfg report number 8010762-2021-00241).The user initially tried to prime a first hls set for the same patient but as a noise was noted that hls was not used.That issue is handled under complaint# (b)(4) (hls, mfg report number 8010762-2021-00226) and (b)(4) (cardiohelp, mfg report number 8010762-2021-00240).Device history record: the production records of the affected hls module and set were reviewed on (b)(6) 2021.According to the final test results, the oxygenator with sn (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Product investigation: for further investigation the hls set was send to ecri.The hls module was connected to a cardiohelp (complained under (b)(4)) and primed without any issue.Flow could be achieved.No malfunction could be confirmed.For further investigation, the hls set was investigated by the getinge laboratory on (b)(6) 2021.Upon visual inspection no abnormalities were noticed.The hls set was primed and the functionality of the pump and sensors was tested.Flow could be achieved without any issue.The product worked according to its specifications, no issues were noticed.The involved cardiohelp was investigated by a getinge service technician on (b)(6) 2021 and no issue could be reproduced.The log files were analyzed by getinge life cycle engineering and no errors were found.Medical evaluation: a medical review was performed by getinge medical affairs.Examinations of the cardiohelp system (sn (b)(6), a ch) by getinge and the ecri investigation of the second cardiohelp system (sn (b)(6), b ch) were not able to duplicate the issues reported by the customer in this complaint.Additionally, no performance issues with two differing disposables (a hls and b hls) could be identified in ecri tests.Moreover, no warnings, deficiencies, or low, medium, high, critical priority errors were shown in an examination of the user and service pool information by life cycle engineering.The complaints mentioned that the patient expired while waiting to be placed on support using the cardiohelp system; however, no evidentiary, direct (root) cause of the patient¿s expiration can be assigned to a malfunction of the cardiohelp system or to its associated disposables (hls set).In the absence of more details, it remains unclear if the events reported by the user (i.E.Noise, inability to zero the pressure sensors, and lack of flow) were due to either a single use error or combination of use errors.However, the possibility cannot be completely dismissed.Conclusion: while the review included an evaluation of technical, medical, trending and device history records (manufacturing); it could not be confirmed that the reported failures may be associated with a medical device malfunction.Additionally, the investigation results supported that the reported failures ¿no flow¿ could not be confirmed.The occurrence rate was calculated for the reported failure 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).

• 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: 11593989
• MDR Text Key: 243106329
• Report Number: 8010762-2021-00223
• 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: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 143 KG