MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted after new information becomes available.

Event Description

Customer called with concerns of a pint = 577.The delta p reading = 407.The customer reported that no clot was observed within the circuit.They were concerned that the pint maybe inaccurate since the patient was oxygenating sufficiently.A short while later the customer then informed me that they were now having to run the pump at 5000 rpm's to maintain a flow of 4.6 liters.This flow was now not sufficient for supporting this covid patient on vv support.The customer was confident the cannulas were positioned correctly and the sizes were 25 fr in the right femoral artery and 23 fr in the right ij.The customer then made the decision to change out the circuit which the patient was able to tolerate and they were then able to increase the flow to 5.7 liters.It was then observed that 2 of the 4 pump outlets were clotted off on the original circuit.In follow-up communication i was informed the circuit had been in use for 17 days.Complaint # (b)(4).

Manufacturer Narrative

Customer called with concens of a pint = 577 with concens of a pint = 577.The delta p reading = 407.The customer reported that no clot was observed within the circuit.They were concerned that the pint maybe inaccurate since the patient was oxygenating sufficiently.A short while later the customer then informed me that they were now having to run the pump at 5000 rpm's to maintain a flow of 4.6 liters.This flow was now not sufficient for supporting this covid patient on vv support.The customer was confident the cannulas were positioned correctly and the sizes were 25 fr in the right femoral artery and 23 fr in the right ij.The customer then made the decision to change out the circuit which the patient was able to tolerate and they were then able to increase the flow to 5.7 liters.It was then observed that 2 of the 4 pump outlets were clotted off on the original circuit.The hls set was directly involved in the incident which occurred during patint 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.A similar case was already investigated under complaint#(b)(4) on 2020-06-05: as stated in the investigation report of ot#(b)(4) clots could be found inside the oxygenator.The most probable root cause are clots in the oxygenator leading to a blockage.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4)) following causes could lead to coagulation: -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.Thus the reported failure could be confirmed.Device history record (dhr) review: affected product: basic lot 70136935 and packaging lot 70136847 (serial number (b)(6)).The avz from 1556391 to 1556400 (dms# (b)(4)) was reviewed on 2020-07-29.There were no references found, which are indicating a nonconformance of the product in question.The occurrence rate was calculated for the reported failure 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 #(b)(4).

• Brand Name: HLS SET ADVANCED 7.0 WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10326105
• MDR Text Key: 203306096
• Report Number: 8010762-2020-00237
• 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: 08/05/2020

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: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Weight: 140