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

Model Number HLS SET

Device Problem Leak/Splash (1354)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hls has a busted membrane and is leaking.The failure occurred during treatment and the hls set was exchanged.No harm to any person has been reported.(b)(4).

Manufacturer Narrative

It was reported that the hls has a busted membrane and is leaking out of the gas outlet connector.The failure occurred during treatment and the hls set was exchanged.The affected product was technically investigated in the getinge laboratory on (b)(6) 2023.During inspection, visible blood residues on the gas outlet of the hls module, besides blood residues and partial clots on both the blood side and the gas side were confirmed.A leak test was performed at the water, gas, and blood side of the product.The leak test confirmed a leakage at the gas outlet (leakage originated from the blood/gas side).The exact root cause remains unknown.However, the most probable root cause of the failure could be caused by the following: - insufficient pur (polyurethane) potting of the mat package - fiber detachment in the pur potting - fiber damage a risk review was performed on (b)(6) 2023.The failure is mitigated in the current risk assessment hls set advanced, hit set advanced in risk id 7.3.6.3.1 (leakage), 7.3.2.1.2 (leakage) and 7.3.2.1.3 (pathogenicity).The threshold for risk acceptability for risk id 7.3.6.3.1 (leakage), 7.3.2.1.2 (leakage) and 7.3.2.1.3 (pathogenicity) has been defined as ptotal = 2 in the risk assessment.The occurrence rate of ptotal = 2 corresponds to n = 0,05 according to the risk management plan of the hls set.The reported 3 complaints (review period from (b)(6) 2022 till (b)(6) 2023 for article number (b)(4)) is applicable to 9561 products sold in one year.This corresponds to an occurrence rate 2 (see above), which is below the acceptance threshold according risk management plan.As stated in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0, in the chapter 7.2 "indications for replacing the set" it is stated "replacement of the set can be indicated in the following cases: leakage, penetration of air, visible deposits in the set, increase in pressure drop, insufficient oxygenation or carbon dioxide elimination at maximum gas flow or 100% fio2".The production records of the affected hls module were reviewed on (b)(6) 2023 for the reported failure.According to the final test results the product passed the tests as per specifications.Based on the investigation results the reported failure "hls busted membrane and leaking gas outlet connector" 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 failure and product 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: 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: 17675707
• MDR Text Key: 323198509
• Report Number: 8010762-2023-00436
• 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: 12/13/2023

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 Expiration Date: 01/16/2024
• Device Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000291125
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1