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

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 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) 1980. Suspected severe pulmonary embolism. Pamela described that the patient was obese. Patient weight was reported as 143 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. This video is attached to this complaint. 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) 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).

• 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: 11594595
• MDR Text Key: 243101722
• Report Number: 8010762-2021-00226
• 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

• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Type of Device Usage

Patient Treatment Data

Date Received: 03/31/2021 Patient Sequence Number: 1