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 Problems Failure to Calibrate (2440); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  Death  

Manufacturer Narrative

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 it was not possible to zero the pressures.Further the pump made an unusual noise during priming.While setting up another circuit the patient expired.See detailed description from customer below: "(b)(6) stated that she was requested to prime a cardiohelp circuit and provide for use in the er for a patient.A female patient with a date of birth was (b)(6).Suspected severe pulmonary embolism.Pamela described that the patient was obese.Patient weight was reported as (b)(6) kg but the patient height was not available.The patient was receiving chest compressions for two hours prior to attempting to place the patient onto cardiohelp therapy.(b)(6) stated she initially attempted to prime the hls circuit with lot number 7014365 on the cardiohelp console with serial number (b)(4).She stated that the circuit was dry but she was not able to zero the pressures.She abandoned attempting to zero the pressures and released the priming solution to prime the circuit via gravity.Once the prime by gravity was completed she set the rpms of the system to 3000 rpms and immediately started to hear a noise.She set the rpms to zero and then set the rpms to 3000 and heard the noise again.Due to this noise she set the rpms to zero, powered down the system and isolated it.Later she was able to replicate the noise and captured a video with sound of the noise.When i arrived on monday (b)(6) 2021 the pump and circuit were isolated and still attached.The circuit was still primed with solution and (b)(6) were able to show me that it was no longer making noise and was achieving flow.The circuit and pump are currently isolated in the perfusion office.I advised that i would be report this complaint and request a biohazard kit to be sent to the facility for the return of lot 70143635.I advised them that their biomed team could contact getinge service to request a pump inspection via their premier service plan for this pump via contract number (b)(4).Please note that this circuit and this pump was not used on the patient." 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 pump made unusual noises during priming and the pressure were not able to be zeroed.The device was not being used for treatment.The used cardiohelp is handled under complaint# (b)(4) (mfg report number 8010762-2021-00240).The user tried to prime a second hls set for the same patient and could not achieve any flow.That issue is handled under complaint# (b)(4) (hls, mfg report number 8010762-2021-00223) and (b)(4) (cardiohelp, mfg report number 8010762-2021-00241).The customer provided a video of the hls set in use.The reported noise was heard.Device history record: the production records of the affected hls module were reviewed on (b)(6) 2021.According to the final test results, the oxygenators 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.No noise was noted during different flow and rpm settings.No malfunction could be confirmed.The involved cardiohelp (complaint# (b)(4)) was checked by a getinge service technician on (b)(6) 2021 and no noise or sound could be reproduced (refer service report (b)(4)).In addition the log files were reviewed by getinge engineering (life cycle engineering) and no error or issue could be determined.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.All pressure sensors could be zeroed and no unusual pump noise was found.The product worked according to its specifications, no issues were noticed.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 ¿pressure calibration issue¿ and ¿unusual noise¿ 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: 11594919
• MDR Text Key: 243123870
• Report Number: 3008355164-2021-00008
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 70105.2794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2021
• Distributor Facility Aware Date: 12/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 143 KG