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

Model Number HLS SET

Device Problems Fluid/Blood Leak (1250); Increase in Pressure (1491); Pressure Problem (3012)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.H3 other text : device already discarded by customer.

Event Description

It was reported that it was noticed by the customer that the yellow cap was off and that ¿plasma¿ filled the port where the yellow cap needs to sit on.The failure occurred during treatment.Under the oxygenator fluid was noticed (lining the metal tray beneath the gas outlet).It is unknown how long the yellow cap has been off.There was a delta pressure alarm, as delta pressure increased and therefore the hls set was exchanged.After the exchangement the delta pressure was back to normal.The flow never changed.The affected hls set was discarded by the customer as the patient is infected with hepatitis c.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that it was noticed by the customer that the yellow cap was off and that ¿plasma¿ filled the port where the yellow cap needs to sit on.Under the oxygenator fluid was noticed (lining the metal tray beneath the gas outlet).The failure occurred during treatment.It is unknown how long the yellow cap has been off.There was a delta pressure alarm, as delta pressure increased and therefore the hls set was exchanged.After the exchangement of the product, the delta pressure was back to normal.The affected hls set was discarded by the customer as the patient is infected with hepatitis c.Therefore a technical investigation could not be performed.However, according to the hls set risk assessment following root cause can lead to the reported failure: de-airing valve remains open throughout the perfusion procedure.Referring to the instruction of use chapter "safety instructions for the oxygenator" it is stated to ensure that the de-airing membrane of the oxygenator is closed with the yellow protective cap during operation.Based on the results the reported failure "leakage and pressure issue due to missing yellow cap" could be confirmed, but was not related to a device malfunction.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.H3 other text : device already discarded by customer.

• 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: 18291302
• MDR Text Key: 330048208
• Report Number: 8010762-2023-00609
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1