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

Model Number HLS CANNULA + PIK

Device Problem Defective Device (2588)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''dilators rupture and bending.'' (b)(4).

Manufacturer Narrative

It was reported that during the procedure of vessel dilation it was encountered to a hard object when the pik set placed, and replaced with another dilator.The same problem occurred with the second dilator in the set.The product was investigated in getinge laboratory on 2021-02-24.The dilators were cleaned.No blood residues could be found during the flushing process.A deformation was determined at the tips of the two thinnest dilators in the set (12 mm diameter and 14 mm diameter).No abnormalities could be detected in the remaining parts in the set.The sample investigation shows that the dilators are deformed and partially broken at the tip.No defects were reported prior to use by the customer.Since two dilators are damaged with the same kind of defects it is likely that this deformation caused by a wrong interaction in the application.It is probable that the guidewire was pulled of through the introducer in a too straight angle with a very high amount of force.The device history record for lot 92272256 was reviewed on 2021-03-03.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.No manufacturing problem was detected.Based on the investigation results, the reported failure could not be confirmed.The most probable root cause was determined as ¿user interaction¿.The reported failure is part of current risk management file dms (b)(4).Chapter h.2.19.4.The most probable causes are associated with user error.The mitigations are in place per design specification and instruction for use warnings.Mit-034 ifu warning: modifications to the device can result in serious injuries to or death of the patient.Do not modify the device.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.

Event Description

Complaint: # (b)(4).

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10776920
• MDR Text Key: 214332576
• Report Number: 8010762-2020-00371
• 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: 03/09/2021

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: HLS CANNULA + PIK
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 84