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

Model Number BEQ-HLS 5050 USA #SHLS SET ADVANCED 5.0

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a leakage on the hls set and therefore it was exchanged.The failure occurred during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that there was a leakage on the hls set at the gas outlet and therefore it was exchanged.The failure occurred during treatment.No harm to any person has been reported.The affected hls set was investigated in the getinge laboratory on 2024 (b)(6) with the following conclusion: the failure could be confirmed.No damage was found during visual inspection.Blood residue was found on the gas outlet and the gas side, confirming a blood leak from the blood-carrying side.The exact root cause is unknown.Probable root causes are: insufficient pur (polyurethane) potting of the mat package.Fiber detachment in the pur potting.Fiber damage.As stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 - in chapter 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.¿ furthermore, it is stated in chapter priming the system ¿check the device for leaks during priming.Do not use the device if there are any leaks.¿ and ¿before priming the set, run water through the heat exchanger of the hls module advanced and check for leaks.¿ the production records of the affected product were reviewed on 2024-01-04.According to the final test results, the product passed the tests as per specifications.Production related influences are unlikely.The review of the non-conformities has been performed for the reviewed time period.It does not show any non-conformity in regards to the reported product and failure.Based on the results the reported failure "gas outlet leakage" 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.According to our risk review the reported failure corresponds to an occurrence rate of 0.01% and ptotal = 2, that corresponds to n = 0.05, which is below the acceptance threshold according to the risk management plan of the hls set and is in the category of ¿3:justifiable¿ risk.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: TUBING SET
• 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: 18423537
• MDR Text Key: 331922531
• Report Number: 8010762-2024-00002
• 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: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 5050 USA #SHLS SET ADVANCED 5.0
• Device Catalogue Number: 701069077
• Device Lot Number: 3000292253
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1