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

Model Number BE-PAL 1923#BE-HLS CANNULA 19F AL

Device Problem Break (1069)

Patient Problem Exsanguination (1841)

Event Date 10/13/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that cannula got broken when the third suture is fixed to the cannula, massive bleeding occured from the cannula.As a consequences of not achieved permanent recovery of blood circulation, patient expired.Complaint: # (b)(4).

Manufacturer Narrative

It was reported that cannula got broken when the third suture is fixed to the cannula, massive bleeding occurred from the cannula.As a consequences of not achieved permanent recovery of blood circulation, patient expired.The product was received back for investigation in the laboratory of manufacturer.The investigation was performed on 2022-01-11.The hls cannula device was applied to visual control.The laboratory investigation shows a ruptured cannula body, as described in the complaint.The reported failure 'broken cannula' can be therefore confirmed.From the hospital clinical report from the patient¿s case it is known that the cannula was too lose and therefore again fixated to the patient¿s skin.The operators applied additional suing around the cannula.According to laboratory investigation, there were several parts where a blue thread was applied tightly on the cannula.The area on which the blue thread is wrapped around the cannula, it can be assumed that the suing was applied on this section.Also the use of ¿ethibond¿ is mentioned by the hospital clinical case report which is medical suing thread.According to the given information of the hospital case description and the investigation from the laboratory, the most probable root cause is a failure of the user/operator by not using the fem clamp for fixation (accessory ¿removable skin attachment¿ according instruction for use (ifu) wording) and directly suing the cannula to the patient¿s skin at the wire reinforced section with medical thread.This most probably caused the rupture of the cannula.The investigation concluded that the failure could not be attributed to the device associated malfunction.The rupture on the cannula body could be confirmed during visual control.The additional suing applied around the cannula body could be confirmed during visual control.The production history record (dhr) of the affected be-pal 1923#be-hls cannula 19f al with lot# 3000162126 was reviewed on 2021-10-22.According to the dhr results, the product be-pal 1923#be-hls cannula 19f al passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Further, the receiving inspection reports of the affected parts lot #3000161506 & #3000161507 cannula bodies were reviewed.All products were passed controls as per specifications.Sterilization parameters of the cycle this batch was in found to be in compliance with specifications.Medical review was performed on 2021-10-29.According to the review conclusion: based on the information provided, the product failure, and patient outcome was the likely result of a use error.The hls cannulas are not to be secured in the wire re-enforced area with sutures.Disruption of the cannulae wall can result as described in the caution section of the ifu.The softened material wire reinforced area of the cannulae permits traumatic vascular insertion and flexibility during therapy.The cannulae body in the wire re-enforced area can be damaged or even cut by suture materials either acutely or by gradual erosion during extracorporeal support.Dedicated skin attachment accessories and hardened areas (barbed connectors) of the cannulae are to be used as per the ifu for securing the cannula to prevent degradation of the cannula wall.The expiration of patient does not appear to be directly related to a either a malfunction or decrease in the performance of the product.The most probable root cause is a failure of the use(r) error.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint: #(b)(4).

• Brand Name: CANULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12698195
• MDR Text Key: 278381442
• Report Number: 3008355164-2021-00029
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: EN
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2023
• Device Model Number: BE-PAL 1923#BE-HLS CANNULA 19F AL
• Device Catalogue Number: 701047287
• Device Lot Number: 3000162126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2022
• Distributor Facility Aware Date: 01/11/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Prefer Not To Disclose