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

Model Number HLS SET

Device Problems Device Sensing Problem (2917); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2023

Event Type  malfunction  

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

The event occurred in france.It was reported that during unpacking of the hls set the sensor flat cable of the hls module was damaged.The customer used the affected hls module and had problems with the pressures during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that during unpacking of the hls set the sensor flat cable of the hls module was damaged by the customer.The customer used the affected hls module and had problems with the pressure reading during patient treatment.The affected product was not available for technical laboratory investigation of the manufacturer.Despite several attempts no information about the return of the product was provided.Additional the customer did not provide the lot number of the product.However, the reported failure "problems reading pressures" can be linked to the following most probable cause according to our risk management file: -flexible circuit board damaged, no data based on the investigation results the reported failure "problems reading pressures" could be confirmed but was most probable not associated with a product related malfunction.As the flexible circuit board was damaged by the customer during unpacking the device, which results to the pressure reading problems.In order to avoid re occurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-360 v03 - nonus 6.1 preparation and installation - perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.Carry out the calibration for each pressure parameter of the integrated sensors.6.2 priming the system do not use the device if the surface of the measuring cell is damaged.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.H3 other text : hls set is not available for investigation, discarded.

• 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: 16276112
• MDR Text Key: 308927724
• Report Number: 8010762-2023-00060
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1