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

Model Number BE-PAS 1915#

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, after shifting to the prone position during v-v ecmo, the luer port cap of the blood feeding cannula came off and blood leakage occurred.Customer tightened the luer port cap and had no effect on the patient.(b)(4).

Manufacturer Narrative

It was reported that the luer cap at the connector of the hls cannulae came off.It was noticed during on patient use while the patient was on prone position during ecmo.The user tightened the luer cap and it was reported there was no effect on the patient.The product was discarded therefore it is not available for investigation.Device history record review could not be performed as lot number of the affected product was not provided.However it was reported that users check the cap tightening before use and no problem was reported noticed before use.Therefore manufacturing error untightened cap could be excluded.The below components are affected parts in this complaint: (b)(4) / 00501#schraubkappe llm.(b)(4) / 00285#konnektor 3/8 x 3/8 ll.Due to absence of lot number, the lot numbers of these components could not be identified.However, non-conformity (nc) trend search was performed based on component material numbers and no nc was found for the reported failure during manufacturing of hls cannula.It was reported that event occurred after shifting the patient to the prone position during vvecmo and customer would like to know about the existence of events overseas and how to improve them.During review of the trend search results, no other complaint was found within the last 12 months.Therefore, this has been considered a single event.No further actions are necessary at this time.In regards to the position changes, there is warning in the (instruction for use) ifu of hls cannulae: ifu information: if the patient is repositioned or transported, there is a risk of decannulation caused by strain on the tubing and mechanical damage.The greatest care should therefore be exercised when carrying out these measures.The exact root cause of the complaint could not be identified.However, with reference to the risk assessment (hls cannulae dms #992734 v04 ) the following events can contribute to detachment of luer cap at the connector of the hls cannulae: unintended opening of luer connection.Mechanical damages occured when repositioning the patient (e.G.During patient transport or repositioning).Mitigations are in place per manufacturing processes and ifu: basic operation procedures (bop): check the mounted parts if there is damage.There shall be no damage on the tube, connector and cap surface.There shall be no crack on the tube, connector and cap surface.Connection well-between tube, connector and cap.Ifu: caution: if you use the arterial cannula, check the luer lock caps are secure before use.Information: if the patient is repositioned or transported, there is a risk of decannulation caused by strain on the tubing and mechanical damage.The greatest care should therefore be exercised when carrying out these measures.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.During review of the trend search results, no other complaint was found within the last 12 months.Therefore, this has been considered a single event.No further actions are necessary at this time.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: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12016580
• MDR Text Key: 256723189
• Report Number: 8010762-2021-00357
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-PAS 1915#
• Device Catalogue Number: 701047282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Patient Sequence Number: 1