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

Model Number BE-PVS 2338#BE-HLS CANNULA 23F VS

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"the venous ecls drainage cannula cannot be advanced into the vessel after appropriate preparation.Users felt strong resistance from the system.A second cannula could easily be advanced through the same puncture site." complaint: (b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

The product was received back for investigation.Cannula was cleaned according to procedure lv 205.Cannula was inspected visually under microscope and with the exception of a few minimal dents in the plastic layer of the drainage annular, no abnormalities could be observed.The provided pictures from the laboratory investigation shows that cannula has no obvious functional defects what could have resulted in to the issues at the insertion.From the technical point of view (based on the microscope images), the cannula is not assumed to have a dysfunction.The closed ¿bubbles¿ (in the pvc cannula body; also visible in the images) are not known to have negative impact while the insertion (and in general).A getinge employee was also at the event site at the time event occurred.It was reported that for better dilation an insertion aid was used and insertion process was performed properly.No any abnormality was detected with the annular.After physician felt resistance, didn't insert the cannula too much force.No harm to patient or user was reported.The second cannula was easily inserted through the same insertion site without any problems by physician.Based on the information obtained so far within this investigation that it could be concluded there is no device problem.The reported failure is identified as part current risk management file dms #1992719 v04 and chapters h2.2.10, h2.4.4, h2.4.11, h2.4.12, h2.4.14, h2.4.19.The most probable causes are associated with wrong design and user error.Mitigations for this specific failure are in place per design specification and instruction for use.Possible use error can be listed as: too much force on cannula; cannula and introducer are introduced too far into the vessel; user chooses wrong size of cannula.It was stated during investigation that customer didn't insert the cannula too depth and didn't apply too much force and the size of the cannula is appropriate since second cannula was same size.Based on the information above the most probable cause could be user interaction - inappropriate movability of cannula and introducer in vessel during insertion.The user error is mitigated with below information in the instruction for use: -a lack of knowledge on use of the device can result in serious injuries or death.-the device must only be used by an experienced / trained physicians.-the physician in charge of treatment is responsible for the procedure and correct use of the device.-the physician must be experienced in vessel cannulation procedures and the proper handling of complications.-within the intended flow rate, the device can be used for all patients irrespective of age, body weight and gender.-the device is intended to be used in a clinical environment under aseptic conditions.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.Device history record for lot 92256006 was reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.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.

• 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: 10499445
• MDR Text Key: 206127879
• Report Number: 8010762-2020-00289
• 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: 12/17/2020

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: 02/03/2021
• Device Model Number: BE-PVS 2338#BE-HLS CANNULA 23F VS
• Device Catalogue Number: 70104.7292
• Device Lot Number: 92256006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/21/2020
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 75