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

Model Number BE-PAL 1723

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

The complaint is received from authority report.It was reported that the clinician noticed a low flow alarm and tried to adjusted the flow speed on the ecmo device however could not manage.After that, a blood leakage was detected from the crack.The exact location of the crack and amount of the blood loss are not reported.No harm to any person was reported.Complaint #(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

The complaint is received from authority report.It was reported that the clinician noticed a low flow alarm and tried to adjusted the flow speed on the ecmo device however could not manage.After that, a blood leakage was detected from the crack.The exact location of the crack and amount of the blood loss are not reported.No harm or death to any person was reported.The sample investigation could not be performed since the product could not be provided due to china custom regulations.Besides, a picture was not provided showing failure.Since due to this issue the clinician stopped ecmo treatment and decannulation the complaint could be confirmed.Additional information was received from getinge representative on 2023-11-13.Information is as below: - there was not any defect detected on the product before use.- customer changed the patient position however more details were not provided.- crack was found on second day of treatment.The production history record (dhr) of the affected be-pal 1523 with lot# 3000312017 was reviewed on 2023-11-15.According to the dhr results, the product be-pal 1523 passed the defined manufacturing and final release specifications.Besides, the customer did not find any defect on the product before and the crack was detected on the second day of usage.Thus, production related influences are unlikely.Exact location of the crack was not reported by customer therefore the incoming inspection report review has been performed for both component ¿701046340, fem body17_al-01#peri.Cath.Body 17fr, al¿ and ¿700000285, 00285#konnektor 3/8 x 3/8 ll¿.Further, the incoming inspection report (batch # 3000253964) of the affected component "700000285 / 00285#konnektor 3/8 x 3/8 ll" was reviewed on 2023-11-15.The connector were checked for damages, scratches, marks, rills, sinks, streaks, and cords visually.Visual tests were passed as per specifications.Due to this, material related influences are unlikely.Also, the incoming inspection report (batches # 3000298282, 3000298285, 3000298287, 3000305497, 3000305504, 3000305505 and 3000305506) of the affected component " 701046340 / fem body17_al-01#peri.Cath.Body 17fr, al" was reviewed on 2023-11-15.The catheter body were checked for open bubbles, particles, ridges, sharp edges, cracks, streaks, dirt, black spot and air bubbles visually.Visual tests were passed as per specifications.Due to this, material related influences are unlikely.The reported failure could be linked to the risk assessment and control of hls cannulae and the probable causes are associated to: manufacturing: - use of wrong or out-of-spec materials user error - lack of attention during device handling: - unintended removal of fem cap from cannula - mechanical damage of cannula connection during removal of fem cap - dearing of cannula (tightening luer cap) - damage of cannula connection during connection of tube line - mechanical damage of cannula during fixation - disconnection of drainage cannula from tubing line these root causes could not be confirmed.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: HLS CANNULAE & PIK
• 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: 18027813
• MDR Text Key: 326798329
• Report Number: 8010762-2023-00533
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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 Model Number: BE-PAL 1723
• Device Catalogue Number: 701047286
• Device Lot Number: 3000312017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other