MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HLS CANNULA 19F AS

Model Number 70104.7282

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Death (1802)

Event Date 01/15/2015

Event Type  Death  

Event Description

It was reported that on (b)(6) 2015 it came to be known that there was a dislocation of an arterial ecmo cannula, which was placed percutaneously on (b)(6) 2015.The pt eventually expired in the further course, although the cause of death is not clearly related to the dislocation.This event was reported to the swiss authority by the medical management and is under official investigation.The cannula was inserted and positioned without any problem and fixated in accordance with the enclosed instructions for use, using the holder provided for this purpose and fixated to the skin.The tight fit was checked by the surgeon as well as the perfusionist.The dislocation took place insidiously and was noticed on the next day during the night.The product is not available for eval.The treatment was a venous-arterial procedure and the product in question was placed femorally.Because of the ongoing legal investigation, the perfusion protocol as well as further event recording is inaccessible.(b)(4).

Manufacturer Narrative

The mfr could not obtain the product in question or the lot number of the product.The mfr has not received info of similar incidents in regards to the product in question and the accessory skin fixation.A clinical eval of the available info was performed and based on the info available to the mfr at this time, there is no indication that the hls cannula or the accessory skin fixation has been flawed.R&d was informed of the customers suggestion to rework the ifu with complemental info on the skin fixation.R&d will examine all available info to consider possible changes to the ifu for enhanced customer satisfaction.Based on the info available to the mfr at this time a malfunction of the product in question cannot be confirmed.

• Brand Name: BE-HLS CANNULA 19F AS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4897930
• MDR Text Key: 6070433
• Report Number: 8010762-2015-00786
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70104.7282
• Device Catalogue Number: BE-PAS 1915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death