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

Catalog Number 70103.5634

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''during initiation of bypass there was a leaking vent valve.'' complaint # (b)(4).

Manufacturer Narrative

The quadrox-i adult was directly involved in the incident which occurred after perfusion.It was reported that luer lock connector is broken.The product has been requested from the customer.The affected luer lock connection for material fatigue (e.G.Crack) was checked with another oxygenator by the identical lot 92290990 (oxygenator lot 70134054).During the visual inspection of the affected oxygenator, the broken luer connector on the oxygenator blood outlet side and on the connector attached to the tube on the blood outlet side was found.The broken luer was not sent.The luer of a reference sample from the identical lot shows no abnormalities on the injection molded part with regard to damage.The complaint can be confirmed based on the visual inspection and examination with the microscope.It is very likely that too much force was used during assembly so that the luer was damaged.Additional information was requested for this failure.According to the answer, the customer used the product as described in the instruction for use (ifu).The perfusion time was 120 minutes.The system was primed with globulin and mannitol.There was no excessive physical force, the pressure line including a bag to store excessive priming is located on that special luer.The custom pack was not damaged during intrahospital transport.The product was stored in a wall closet with front doors, at room temperature.The user did not use any products on the outside, and no liquid inhalation anesthesia.The user didn¿t use a rubber hammer for de-airing.Max flow was 5,29l/min pressure during the patient time between 180 - 220 mmhg.During priming/testing, fase was the pressure for ½ min 400 mmhg, at that time there was no leakage at that luerlock.The reported failure was identified risk management file dms (b)(4) and chapters r8.2.1.4 , r8.2.1.5, r8.2.1.6.The most probable cause is associated with user error.The mitigation for this specific failure is in place per instruction for use.Device history record for lot 92290990 and lot 70134054 was reviewed.There is no evidence indicating non-conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed and no systemic issue could be determined.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.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).

Manufacturer Narrative

It was reported that the vent valve was leaking during the initiation of bypass.The product was investigated by getinge laboratory on 2021-01-25.During the leak test, it was detected that the vent valve relief was leaked at 267 mmhg pressure.Since the component 70102.5887(vent valve) is an "off the shelf" component which maquet cardiopulmonary purchases from an external manufacturer it was recommended that the manufacturer be involved in the investigation.For further investigation, scar-8d-2027613 was initiated on 2021-02-03.The product was received by the supplier for sample investigation on 2021-02-24.The sample was tested on a rotary pump to simulate the use condition in a lab.Water was circulated through the valve using the rotary pump at 1 l/min and no leak was observed.The rotary pump was reversed to create a backflow in the parts;this ats as if an occlusion in the line.The valve was tested multiple times for backflow and each time, the valve began to leak from under the hood.The minimum opening pressure for the relief band recorded was 240 mm hg.A root cause could not be determined since the sample functioned as intended and a device defect was not identified.No corrective action will be performed at this time since the complaint was not confirmed as manufacture related.The pressure relief band or the vent valve is designed to open up and relieve pressure build up the unit.The pressure relief band has a minimum opening pressure of 90 mm hg and a maximum opening pressure of 570 mm hg.Device history record for lot 92283718 was reviewed on 2020-10-20.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.During assembling of components at antalya site, there is direction controls per fb-005 v13 tubing set control form and per dhr review results, it was performed by operators.Based on the investigation so far, no product problem could be confirmed.In addition, there is capa 259464 ongoing for this issue and product.Within capa, a root cause analysis has been performed and documented.To summarize the root cause analysis, the leakage which has been complain t is not related to a malfunctioning product or tubing set configuration.Laboratory simulation testing showed that the valves perform as intended and show leakage when positive pressure at around 220-240 mmhg is applied to the line.Fishbone diagram was used for root cause determination.It is concluded that root cause is ifu does not describe the mode of action sufficiently with regards to the safety functions of the valve when the valve has been changed to 5887 vacuum ventil.All further actions will be followed by capa 259464.As a corrective action within the capa, additional information for the users that have the quest medical vacuum valve incorporated into their tubing set will be added in ifu.The product failure cannot be confirmed however complaint can be confirmed since the manufacturer did not inform the customers adequately regarding function of the valve by ifu.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: HLM TUBING SET
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10671208
• MDR Text Key: 211254712
• Report Number: 8010762-2020-00338
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70103.5634
• Device Lot Number: 92283718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1