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

Model Number BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0

Device Problem Crack (1135)

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

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that there were small cracks in the clear plastic exterior of the oxygenator.The failure occurred during treatment.Afterwards the information was received that the hls set was not exchanged and used further.The customer has to weigh the risk of changing out the circuit versus continuing to use the circuit as it is.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that there were small cracks in the clear plastic exterior of the oxygenator.The failure occurred during treatment.Afterwards the information was received that the hls set was not exchanged and used further with no leakage.The affected hls set was investigated by the getinge laboratory on 2023-05-26 with following conclusion: the visual inspection was performed but cracks could not be confirmed, instead of that these were identified as flow lines.A leak test was performed to confirm the flow lines, thus no leakage could be detected.The reported failure crack in the clear plastic of the oxygenator could not be confirmed.Another hls set was complained as crack, but was also identified as flow lines.According to the instruction for use (ifu, hls set advanced 6.0/7.0, hit set advanced 5.0/7.0) it is stated in chapter 6.1 ¿preparation and installation¿ that the user should perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.The production records of the affected hls module were reviewed on 2023-05-30.According to the final test results, the hls module passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "cracks in the clear plastic of the hls set" could not 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.

Event Description

Complaint id: (b)(4).

• 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: 16442334
• MDR Text Key: 310240688
• Report Number: 8010762-2023-00106
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701068216
• Device Lot Number: 3000226381
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1