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

Model Number BE-PAS 2315 -J#BE-HLS CANNULA 23F AS

Device Problem Difficult to Insert (1316)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

"an attempt was made to percutaneously place an hls cannula (be-pvl2355) using pik150, but the resistance during insertion was so strong that it could not be placed.As a precaution, a smaller size be-pvl2155 was used and successfully placed.The necessary flow rate was secured and there were no problems with ope.There was no effect on patients.The item in question could not be recovered." complaint #: (b)(4).

Manufacturer Narrative

It was reported that an attempt was made to percutaneously place an hls cannula (be-pvl2355) using pik150, but the resistance during insertion was so strong that it could not be placed.As a precaution, a smaller size be-pvl2155 was used and successfully placed.The necessary flow rate was secured and there were no problems with ope.There was no effect on patients.The product is not available for investigation.The customer was not able to provide visual about the failure.The production history record (dhr) of the affected be-pas 2315 -j# with lot # 3000309021 was reviewed.According to the dhr results, the product be-pas 2315 -j# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The review of the non-conformities has been performed.It does not show any non-conformity in regards to the reported product and failure.The mitigations are covered in the instruction for use of hls cannuale and which are: ifu information: "carefully select the appropriate size of cannula for the particular patient.Determine the vessel diameter, if necessary." ifu caution; "if increased resistance is felt during insertion, pull the cannula back and search for the cause with the aid of the appropriate imaging." ifu caution; "do not insert the cannula too far into the vessel." the reported failure "resistance during insertion of cannula" could be linked to the current risk management file of hls cannuale and the most probable causes are linked to: user: cannula and introducer are introduced too far into the vessel.Vessel outflow occluded by cannula.The user didn´t perceive or recognize how to choose the correct size of cannula.These root causes could not be confirmed.Since during the event a smaller size hls cannula was successfully placed the product problem could not be confirmed.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.

• Brand Name: CANNULA & CATHETER
• 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: 18129379
• MDR Text Key: 327995805
• Report Number: 8010762-2023-00568
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2023

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: BE-PAS 2315 -J#BE-HLS CANNULA 23F AS
• Device Catalogue Number: 701067489
• Device Lot Number: 3000309021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose