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

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

Device Problem Increase in Pressure (1491)

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

Event Date 11/07/2021

Event Type  malfunction  

Event Description

The event occurred in the us.It was reported that the delta p pressure in the hls set climbed higher and higher.No clots were noticed.The patient is stable.The hls set had to be replaced.No harm to the patient has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

The event occurred in the us.It was reported that the delta p pressure in the hls set climbed higher and higher.No clots were noticed.The hls set was replaced during treatment with no consequences to the patient.No harm to any person has been reported.The affected beq-hls 7050 usa#hls set advanced 7.0 with lot# 3000171768 was investigated in the getinge laboratory on 2022-01-18 with the following results: during the investigation of the beq-hls module with lot#3000163290 the reported failure "delta p pressure increased" could not be confirmed.No abnormalities could be detected, which would indicate a defect within the hls module.Based on the investigation results, the reported failure "delta p increased" could not be confirmed.However the failure mode "delta p increased" can be linked to the following most possible root causes according to our risk management file (dms#1468452).Deteriorating gas transfer; blockage of oxygenator; damage of gas fibers; malfunction of oxygenator; too low anticoagulation; too low at level, effect of heparin is too limited; protamine sulfate enters the hls set ; thrombozytopenia.The production records of affected beq-hls module with serial number (b)(6) was reviewed on 2022-01-21 and according to the final test results, the beq-hls module passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.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: 12787147
• MDR Text Key: 280586730
• Report Number: 8010762-2021-00599
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000171768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose