MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SETW/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6), that a hls set was placed on a patient.After two days in use a high delta p hugh pressure and decrease of svo2 was reported.The customer decided to exchange the hls set.No indication of actual, or potential for harm, or death reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the delta pressure increased and the mixed venous oxygen saturation (sv02) decreased during treatment.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.Due to the high risk of spreading the sars-cov-2 virus outside the healthcare environment, a technical investigation of this hls set is not possible as the laboratory of maquet cardiopulmonary gmbh is not suitable for who risk group 3.Furthermore, no external laboratory could be found that could carry out the investigation on our behalf.During the technical investigation of the similar (b)(4) on (b)(6) 2020 clots were detected inside the oxygenator.The most probable root cause for the increased pressure drop are clots in the oxygenator leading to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v25) and in consultation with the manager medical affairs the following events can contribute to clotting in the circuit: de-airing luer lock connection too loose.Air remains in or enters the circuit.Hemostasis.Air or blood remains in luer lock access port.Too low anticoagulation.Too low at level, effect of heparin is too limited.Protamine sulfate enters the hls set.Administration of substitution of congealable substance such as plateles.(consumption) coagulopathy.Thrombozytopenia.Device history record review was performed on (b)(6) 2020 and there were no references found, which are indicating a nonconformance of the product in question.The reported failure "high delta p and decrease svo2" could be confirmed.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.

• Brand Name: HLM TUBING SETW/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10926386
• MDR Text Key: 218962395
• Report Number: 8010762-2020-00414
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Patient Sequence Number: 1