MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 5.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0

Device Problem Improper Chemical Reaction (2952)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

Requested parts and patient data.Not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

Customer stated that po2 levels were dropping abnormally fast, with in about a 24 hour period which is unusual.They changed out the circuit 2 times.The circuits were changed with no incident.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the oxygenation performance of the hls set was decreasing.The hls set was exchanged two times.The devices were being used for treatment.Only the second exchanged hls set was saved by the customer.The second used hls module was investigated in the laboratory on (b)(6) 2021 with following results: during the leak test a leakage at the connection between the blood inlet connector and centrifugal pump (blood inlet channel) was noted.Upon visual inspection stress cracks were noted.The leakage was most probably caused by inclined inlet domes of the blood inlet cover.This results in tensions within the components during the assembly of the pump module, which has led to a stress crack in the blood inlet channel.As there is a negative pressure in the blood inlet channel air can be sucked in the circuit due to the determined leakage.As already determined in the hls set risk assessment air entry can lead to clot formation in the extra corporeal circuit and thus, an reduction of the diffusion path lowering the gas transfer performance.The failure was already addressed in a corrective and preventive action (capa (b)(4)) which was closed effectively on (b)(6) 2021.During the capa investigation it was determined that the inclined inlet domes were caused by missing pressure on the lid during the screwing process.As a corrective action an oxy-carrier was created to ensure a hold down pressure on the lid during the process.The in this case affected hls module was manufactured on 2020-04-30 before the actions were implemented.The initially used hls set was not available for investigation.However, the most probable root cause was also determined as coagulation in the extra corporal circuit.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: air remains in or enters the circuit.Inappropriately low, or no blood flow, in the circuit.Improper hemostasis.Too low anticoagulation.Too low act level, effect of heparin is too limited.Protamine sulfate enters the hls set.Administration of congealable substances (such as platelets) or pro-coagulant medications.(consumption) coagulopathy.Based on the investigation result the reported failure "dropping oxygenation performance" could be confirmed.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 5.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11699229
• MDR Text Key: 246486287
• Report Number: 8010762-2021-00262
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 5050 USA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 701052797
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2021
• Patient Sequence Number: 1