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

Model Number BE-S 2085#

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that the user suspected there was leakage in the connection of back flow.The customer checked the circuit and bubble was found in back flow tubing.They suspected the 3-way of the set have crack.The fault occurred just after applied on patient.The user changed the product to a new one.No harm to any person was reported.Complaint #: (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the user suspected there was leakage in the connection of back flow.They suspected the 3-way of be-s 2085 have crack.The fault occurred just after applied on patient.After the customer primed and applied the back flow on patient, they found the patient getting worse.Then they checked the circuit and bubble was found in back flow tubing.The user changed the product to a new one.After they changed another back flow connection, no bubble was found and patient get stable.The patient was finally weaned ecmo and no harms were reported.The product was investigated in the laboratory of manufacturer.The set was arrived without 3 way stopcocks.The visual controls were performed in order to determine any cracks, deformations.No deformations or cracks were found on the hose and luer caps.Test equipments were set and the setup was conducted to determine the leakage occuracy for the tubing.The system was connected to the roller pump in order to apply high pressure on the system.No leakage was observed.The pressure was over 2 bar and new 3 way valves were added on the system and no leakage was observed.Due to the lack of 3 way stopcock component, leakage test of the suspected component could not be tested.Therefore, the root cause of the leakage coming from the stopcock could not be determined.Based on this, the complaint could not be confirmed.The lot number of the affected tubing set was not provided by the customer.Therefore, dhr (production records) review could not be performed.However, the reported failure could be linked to the current risk management file (dms#1906296, v21) and the most probable causes are associated to: manufacturing process; mechanical damage of tube; lack of attention: additional accessories cannot be mounted.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.

• Brand Name: TUBING SET
• Type of Device: TUBING, PUMP, 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: 16271102
• MDR Text Key: 308487390
• Report Number: 8010762-2023-00059
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-S 2085#
• Device Catalogue Number: 701048535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1