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

Model Number BE-PVL 2555#BE-HLS CANNULA 25F VL

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"when the cannula was inserted by an appropriate method of use and an attempt was made to remove the inner cylinder, the grip on the hand was removed, making it difficult to remove the inner cylinder by a normal procedure.The inner tube was somehow removed with forceps and the cannula was placed." complaint: (b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the product back for investigation on 2019-10-16.Sample received by laboratory of manufacturer on 2019-12-10.Visual investigation was performed and it was found that the handle of the introducer had detached.The existing glue is completely hardened however it was applied too little.In addition, inner part of the handle was checked.No material defect was found.Getinge cp antalya also investigated the complaint.Hls dimension test & tensile test for customer complaints were performed.(trackwise id: (b)(4)) raw materials, introducers and griffs, are measured for fr sizes 21, 23, 25.Gluing process was performed according to process method and tensile test was performed for glued parts.The results were evaluated by using a statistical method and found process is sufficient.It was concluded that the products pass the tensile limit described in en iso 868-5d.Based on the analyzing results and even though material defect on the test samples which are assembled according to basic operation procedure 9204421 revision 03, passed the tensile test.It was verified that introducer dimension results has no meaningful effect on the defect place or tensile test results.However, failed dimension issues were escalated to receiving inspection repsonsibles for improvement.Based on this no method or process problem could be identified.Device history record for complaint (b)(4) and lot 92235144 was reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed and no additional complaint was recorded within last 12 months.The occurence rate regarding this complaint is below the acceptance rate.Thus, no remedial action required.Based on the information obtained so far within this investigation, the most probable cause could be found as operator's inadequate gluing.Getinge cardiopulmonary antalya trained the operators regarding gluing process and informed about the complaint.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

• Brand Name: CATHETERS & CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9201318
• MDR Text Key: 194774572
• Report Number: 8010762-2019-00329
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: BE-PVL 2555#BE-HLS CANNULA 25F VL
• Device Catalogue Number: 70104.7296
• Device Lot Number: 92235144
• Date Manufacturer Received: 12/25/2019
• Patient Sequence Number: 1