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

Model Number BE-HLS 5050 #SHLS SET ADVANCED 5.0

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/26/2022

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

Following was initially reported: ¿a report was sent by the customer to the (b)(6) on july 28, 2022 (by email).(b)(6).Getinge france was also the recipient of this email.Description of the event according to the report sent to the (b)(6): patient: gau, male, 64 years old, 90kg.Maastricht iii organ removal procedure for the patient.Before the therapeutic stop, the circuit is assembled and purged.When the purge is complete, the doctor puts the circuit in a closed circuit and starts the crn machine to circulate the physiological serum and allow the circuit to be degassed.At this time, the doctor notices a leak of liquid between the 2 artery and vein connectors at the level of the white clip.The circuit was removed and the 2nd circuit was purged and fitted without any problem.¿ according to the (b)(6) authority report from the customer, there was a delay in treatment.The failure occurred during priming.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

Following was initially reported: ¿a report was sent by the customer to the ansm on july 28, 2022 (by email).(b)(4).Getinge france was also the recipient of this email.Description of the event according to the report sent to the ansm: patient: (b)(6), male, 64 years old, 90kg.Maastricht iii organ removal procedure for the patient.Before the therapeutic stop, the circuit is assembled and purged.When the purge is complete, the doctor puts the circuit in a closed circuit and starts the crn machine to circulate the physiological serum and allow the circuit to be degassed.At this time, the doctor notices a leak of liquid between the 2 artery and vein connectors at the level of the white clip.The circuit was removed and the 2nd circuit was purged and fitted without any problem.¿ according to the ansm report, there was a delay in treatment.The affected product was investigated in getinge laboratory on 2022-09-21.The area of the hose set marked by the customer/user according to the illustration and adhesive tape was thoroughly inspected for any visually visible damage and deviations.Furthermore, a functional test was carried out.No damage and/or deviations on the hose set (quick coupling, connection hose to quick coupling, etc.) could be identified which could have led to a leakage.The complaint description could not be technically reproduced.However, according to the risk assessment following root causes can lead to the reported failure: quick-action coupling is not tight.Connection to loose.Moreover in the instruction for use of the hls set advanced 5.0 / 7.0 (chapter 4.2 safety instructions for the extracorporeal circulation) it is stated to attach the tube connections correctly, to secure all connections and to avoid excessive tension and check the integrity and leak-tightness of the components immediately.The production records of the affected be-hls 5050 #shls set advanced 5.0 were reviewed on 2022-09-22.According to the final test results, all be-hls 5050 #shls set advanced 5.0 with lot#3000189718 passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "leak of liquid between 2 artery and vein connectors at the level of the white clip" could not be confirmed.The customer will be informed about the results by the getinge sales and service unit.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.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.

• 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: 15173082
• MDR Text Key: 305273920
• Report Number: 8010762-2022-00304
• 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,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 5050 #SHLS SET ADVANCED 5.0
• Device Catalogue Number: 701069076
• Device Lot Number: 3000189718
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG