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

Model Number HLS CANNULAE VENOUS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"we received the information that the university(b)(6) had issued a (b)(6) message.Description of the event: cannulation of the femoral vessel with specified medical device.When the mandril was removed, the required plug was released without applying any force.Thus, the stylet was difficult to remove.This could have invaded the patient uncontrollably and injured vessels.Medical device was made safe." (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh is aware of similar complaints.Similar product, showing a similar malfunction has been already investigated within #(b)(4): 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 responsible for improvement.Based on this no method or process problem could be identified.Device history record for lot 92284969 was reviewed.There were no references found which are indicating a nonconformance of the product in question.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.

Event Description

Complaint: #(b)(4).

• 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: 9394748
• MDR Text Key: 168594901
• Report Number: 3008355164-2019-00017
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: HLS CANNULAE VENOUS
• Device Catalogue Number: 70104.7270
• Device Lot Number: 92284969
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2020
• Distributor Facility Aware Date: 01/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention