MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HLS CANNULA 23F VL; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PVL 2355#BE-HLS CANNULA 23F VL

Device Problem Break (1069)

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

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturers laboratory investigation but has not yet been received.The investigation of the manufacturer is still pending.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: the product was to be used on a patient, and hospital user realized a broken point in the cannula's end point.Thus, user did not use this product and replaced it with a new one.No problem occurred in the replaced product.(b)(4).

Manufacturer Narrative

Investigation has been performed in our laboratory.In the visual examination of the cannula,it was determined that it is not straight but wavy in the sterile bag.After unpacking from the sterile bag,a damage was detected approximately 4cm before the end of the cannula.Also,complaint has been investigated by mcp tr.During production and packaging steps,the claimed products are checked visually,based on the basic operation procedures.The packaging design of the product is reviewed,so that the product cannot move within the package.Also,the samples have been tested by applying excessive force,and cannot be damaged similar to the complaint.Therefore,assembly and packaging failures can be eliminated.A review of the device history record was performed with no abnormality found.The pictures of the complaint have been reviewed,and it is realized that the sterile bag is not a product used in the production.Therefore,it could be possible that the claimed cannula can be used more than once.Based on this situation the complaint is not related to our production.A trend search has been performed which came to following results:no additional complaints were recorded.This is the failure was determined to be the first of its kind.Due to this information no systemic issue could be determined.Although the failure was confirmed,the most probable root cause could be determined as an user failure.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.This data will be handled through a designated maquet trending process.If at trend occurs,it will be escalated to qa management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: BE-HLS CANNULA 23F VL
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6128689
• MDR Text Key: 61198819
• Report Number: 8010762-2016-00686
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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: 09/01/2017
• Device Model Number: BE-PVL 2355#BE-HLS CANNULA 23F VL
• Device Catalogue Number: BE-PVL 2355#BE-HLS
• Device Lot Number: 92183105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1