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 Problems Mechanical Problem (1384); Pressure Problem (3012); Temperature Problem (3022)

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

Event Date 10/04/2023

Event Type  malfunction  

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 that customer recently placed a patient on support on the cardiohelp-i.After initiating support customer were unable to receive the part, tart, and delta p data.Customer attempted to disconnect black internal sensor cable and reconnect without resolution.Upon inspection, customer noticed the green cable running along bottom of hls module on the arterial outlet was loose.Patient remains on the hls set at this time.The customer decided to continue on support at this time with no monitoring of part or tart.No external monitoring used at this time.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that customer recently placed a patient on support on the cardiohelp-i.After initiating support the customer was unable to receive the pressure and temperature readings (part, tart, and delta p).The black internal sensor cable (hls cable) was disconnected and reconnected without resolution.Upon inspection, the customer noticed that the green cable (flex line), running along the bottom of the hls module on the arterial outlet, was loose.The patient remained on the hls set and the customer decided to continue the support with no monitoring of pressure or temperature readings.No external monitoring was used.The affected product was investigated by the getinge laboratory on 2024-03-26 with following conclusion: the failure could be confirmed.The flex line was damaged.The most probable root cause is a intra-hospital transport damage or high external force.According to the instruction for use of the affected product in chapter "preparation and installation" it is stated that the pressure sensors have to be checked before priming.Further the cardiohelp has a flow/bubble sensor and a venous probe to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.The device history review was performed for the affected module, as the failure is related to the module and not to the set.The production records of the affected product were reviewed on 2024-03-26.According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "pressure and arterial temperature failed" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.

• 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: 17928519
• MDR Text Key: 325587107
• Report Number: 8010762-2023-00494
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069078
• Device Lot Number: 3000273329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1