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

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

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"when attempting to insert the hls cannula be-pvl 2355, the head of the stylet broke off." when trying to insert hls cannulae, handle of the introducer broke off.Complaint: # (b)(4).

Manufacturer Narrative

The product be-pvl 2355 hls cannula was directly involved in the incident which occurred when attempting to insert the cannula.It was reported that a handle of the introducer broke off.Photograph showing the failure was provided via cellphone and attached to this record.Getinge cp antalya decided not to investigate the sample due to the fact that the failure is known to manufacturer and there is capa (corrective and preventive action) for this product and failure.The failure could be confirmed.Device history record for lot 92284725 was reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.For similar complaints getinge cp antalya performed a test in order to identify the brekage forces of introducer / griff connections.The test plan '2020-02-20-01 test plan introducer-griff tensile testing' and test report '2020-02-20-01 test report introducer-griff tensile testing' were created.As a result of this test, all samples are conforming according to statistical analysis realized with minitab19 stastistical control program.Defined acceptance criteria 15 n fmax and cpk 0.71, were all passed by both partial (type based) and total analysis.The receiving inspection reports of introducer-handle and adhesive chemicals were reviewed.No any nonconformity could be detected.The reported failure is identified as a part of current risk management file (b)(4).The mitigation for this specific failure is in place per design specification.Futhermore, there is 100% control in accordance with si-b-289 rev0 with an equipment which creates 19,64 ± 2,00 n vertical force on grip.Trend search was performed.No systemic issue could be detected at this time.Nevertheless, getinge cp antalya initiated capa 296548 based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.Capa was initiated on 2020-02-24.Capa root cause investigation has been done with 6m method on 2020-04-30.It was concluded in the investigation report of this capa: "when the process and process inputs are evaluated together with the literature, studies are carried out to determine the process parameters that can stabilize the process.With the study, it was aimed to both determine the causes of the type of adhesive failure and to reveal the parameters that can be validated in validation stages.It is a sensitive process when the process is evaluated together with the adhesive and glued "hard to bond" material.The process is carried out manually with the current bop.As a result; there are determined 3 root causes as below; rc1: bop is not sufficient in terms of the gluing method and tensile test method.Rc2: pra is not sufficient in terms of adhesion integrity failure.Rc3: validation of bop 9204421 rev03 is not sufficient since parameters are not determined/defined exactly.In order to eliminate these root causes, actions will be determined in the action plan section of this capa." regarding similar complaints, getinge cardiopulmonary antalya trained the operators regarding gluing process and informed about the complaint.All further steps will be performed in accordance to capa 296548.All actions were implemented on 2020-09-18.This complained product was manufactured before the all corrective actions are implemented in capa 296548.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary and further investigations and measures will be conducted 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: 10478653
• MDR Text Key: 207965780
• Report Number: 8010762-2020-00284
• 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: 10/13/2020

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: 05/29/2022
• Device Model Number: BE-PVL 2355#BE-HLS CANNULA 23F VL
• Device Catalogue Number: 70104.7295
• Device Lot Number: 92284725
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/13/2020
• Patient Sequence Number: 1