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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Leak/Splash (1354)

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

Event Date 06/30/2022

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

The event occurred in united kingdom.It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.The affected product was investigated in the getinge laboratory on 2022-09-02.During visual inspection no damage or abnormalities could be detected.During the performance of the leak test blood side, a leakage occurred from the emergency gas outlet of the product.Therefor the reported failure could be confirmed.The exact root cause could not be determined.The most possible root cause could be determined as the following: insufficient pur (polyurethane) potting of the mat package.Fiber detachment in the pur potting.Fiber damage.The production records of the affected be-(b)(4) #shls module advanced adult with lot#3000210013 were reviewed on 2022-09-06.According to the final test results, the hls module with lot#3000210013 and udi#(b)(4).Passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "leakage at the gas outlet connector" could be confirmed.Maquet cardiopulmonary initiated a non-conformance process in regards to the detected findings.All further actions and investigations will be performed within this process.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: 14953092
• MDR Text Key: 301200386
• Report Number: 8010762-2022-00265
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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: 01/11/2023
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000215230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1