MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SET; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BO-HQV 55812

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that a small stream of air continues to be drawn in throughout the case.Replacing the temperature housing with a dead end cap no longer prevent air entrainment.As an action, in some circumstances, the customer tried a number of ports and solutions and this has led to the replacement of the reservoir prior to a case.Other times they¿ve made due.Complaint #: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the venous reservoir temperature sensor port is unable to be completely capped when the venous temperature sensor is moved.A small stream of air continues to be drawn in throughout the case.The fault occurs at the beginning of the case, and is found when priming prior to the initiation of bypass.This has led to the replacement of the reservoir prior to a case.Other times they've made due.The samples are not available at this moment.Based on the obtained information in this investigation, sample investigation is decided not required anymore.The production history record (dhr) of the affected bo-hqv 55812 with lot #3000202570 was reviewed.The production history record (dhr) of the affected bo-02971 #reservoir vhk 71000 softline with lot #3000201861 was also reviewed.According to the dhrs results, the products passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Further the incoming inspection report of the affected component "700000501 / 00501#schraubkappe llm" with lot number 20-9205519 was reviewed on 2022-09-14.The cap was checked for critical dimensions and damages in accordance with plan ri-787/00.All tests were passed as per specifications.Production related influences are unlikely to have contributed to the reported failure.The product was designed and manufactured as temperature connector on pos 2.(ifu, g-159, v08) and ll at the venous inlet with a cap on pos 16.(ifu, g-159, v08).The tight cap is provided assembled on this connector.The customer uses the cap on the venous inlet ll in order to close with cap the temperature connector.The cap on the venous inlet is placed with space at the housing.And could be easily sealed to the connector.However, when this cap is used for temperature connector the cap is placed by contacting the venous inlet housing and could not be properly sealed.This can be also seen in the photograph provided by the customer (img_5621) and attached to the parent record.Besides this, the inner diameter of the temperature probe connector is 4,485 mm while the inner diameter of luer lock at venous inlet is 4,285 mm.As explained above, since the cap on the venous inlet ll is cannot be sealed properly on the temperature connector, the air penetration is likely.The product is supplied with temperature connector with sensor on pos 2.And venous inlet ll connector with tight cap on pos 16.The change is done by the customer as they are moved the venous temperature probe housing from the more anterior position to the more lateral or side position on the hard venous inlet of the quadrox oxygenators as part of our basic set-up.The customer also reported that the issue occurred on all products.Because they change the temperature connector in all cases.The most probable cause is user error ¿changing the connectors and caps on the product¿.Based on this, there is no product problem could be identified.The occurrence rate was calculated for the reported failure and product 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.H3 other text: 4115.

Event Description

Complaint #: (b)(4).

• Brand Name: TUBING SET
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: 15155689
• MDR Text Key: 304879919
• Report Number: 8010762-2022-00302
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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 Expiration Date: 11/02/2023
• Device Model Number: BO-HQV 55812
• Device Catalogue Number: 701070097
• Device Lot Number: 3000202570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1