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

Model Number HLS SET

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The event occurred in usa during treatment.It was reported that the patient was on support with a new hls set and there was blood dripping from the gas outlet.There were no issues with the flow and no alarms.The hls set was exchanged.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

On 2024-02-21 the information was received that the customer reported the complaint to fda (ref.Mw5151132).It was reported that the patient was converted to a new ecmo circuit in the operating room and very shortly after being on the new circuit the perfusionist noted a small amount of blood coming out of the oxygen vent port at the bottom of the oxygenator.Therefore a new circuit was placed on the patient.According to the customer there was no noticeable harm to the patient, but blood cultures were drawn for due diligence to ensure that no contamination of blood occurred.This complaint was reported by the customer as a serious injury to fda.Maquet cardiopulmonary will not report this complaint as a serious injury as the customer confirmed that there was no noticeable harm to the patient, it was a small amount of blood and the hls set was directly exchanged.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that the patient was on support with a new hls set and there was blood dripping from the gas outlet.There were no issues with the flow and no alarms.The hls set was exchanged.The failure occurred during treatment.No harm to any person has been reported.On 2024-02-21, the information was received that the customer reported the complaint to fda (ref.Mw5151132).It was reported that the patient was converted to a new ecmo circuit in the operating room and very shortly after being on the new circuit the perfusionist noted a small amount of blood coming out of the oxygen vent port at the bottom of the oxygenator.Therefore a new circuit was placed on the patient.According to the customer there was no noticeable harm to the patient, but blood cultures were drawn for due diligence to ensure that no contamination of blood occurred.This complaint was reported by the customer as a serious injury to fda.Maquet cardiopulmonary will not report this complaint as a serious injury as the customer confirmed that there was no noticeable harm to the patient, it was a small amount of blood and the hls set was directly exchanged.The affected hls set was investigated in the getinge laboratory on 2024-04-12 with following conclusion: the failure could be confirmed.During inspection, no visible damage were found.Blood residue was found on both the blood and gas side.The leak test confirmed leak originating from the blood-carrying side which resulted in the gas outlet leakage reported.The exact root cause remains unknown.However, the most probable root causes are: insufficient pur (polyurethane) potting of the mat package; fibre detachment in the pur potting; fibre damage.According to our risk review the reported failure corresponds to an occurrence rate of 0.03% and ptotal = 2, that corresponds to n = 0.05, which is below the acceptance threshold according to the risk management plan of the hls set, and is in the category of ¿3:justifiable¿ risk.According to the ifu of the hls set, in the chapter 7.2 indications for replacing the set, it is stated: "replacement of the set can be indicated in the following cases of leakage, penetration of air, visible deposits in the set, increase in pressure drop and/or insufficient oxygenation or carbon dioxide elimination at maximum gas flow or 100% fio2.As far as gas transfer and pressure increase are concerned, the decision to replace the set depends on the particular situation.Assessment of the situation and the decision whether or not to replace the set is the responsibility of the physician in charge of treatment".Based on the results the reported failure "gas outlet leakage" 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 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: 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: 18639166
• MDR Text Key: 334528553
• Report Number: 8010762-2024-00066
• 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,Followup
• Report Date: 05/02/2024

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 Model Number: HLS SET
• Device Catalogue Number: 701069078
• Device Lot Number: 3000344471
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 02/21/2024; 04/12/2024
• Supplement Dates FDA Received: 02/27/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1