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

Model Number AVALON ELITE CANNULA & CATHETER

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

Due to an anonym disposable survey in united kingdom of great britain and northern ireland following was reported: ¿we use dilators from another company.We do not use the size 13f avalon as we had a perforation with one.We regularly do physio with these patients on ecls and one disadvantage is that there is no rotational markings on the cannula to indicate if they have rotated, just depth.¿ the instant of time is unknown.No more information will be available.No harm to any person has been reported.No serious injury or death was reported with the given information.Since no systemic issue was determined no corrective action is required at this time.According to the risk file avalon elite following root causes can lead to the reported failure: use error: misidentification of product, manufacturer or incorrect interpretation of instructions: user applies the product to patient inadequately causing serious injury to the patient.Misidentification of correct cannula placement, selection of correct catheter size, position of side holes do not match with the anatomical conditions of the patient (drain and infuse blood), selection of cannula position (e.G.In conjunction with an additional port or catheter) use error: user did not perceive or recognize to apply the stylet in order to prevent bend during cannulation.Catheter is introduced into the vessel wall; rupture of vessel wall; malperfusion.No confirmation of the failure is possible due to less information as this complaint was created out of anonymous survey.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.

Event Description

Due to an anonym disposable survey in united kingdom of great britain and northern ireland following was reported: ¿we use dilators from another company.We do not use the size 13f avalon as we had a perforation with one.We regularly do physio with these patients on ecls and one disadvantage is that there is no rotational markings on the cannula to indicate if they have rotated, just depth.¿ the instant of time is unknown.No more information will be available.No harm to any person has been reported.(b)(4).

• 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: 14432998
• MDR Text Key: 300333942
• Report Number: 8010762-2022-00177
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2022

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 Model Number: AVALON ELITE CANNULA & CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1