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

Model Number BE-PAL 1723

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The clinician noticed blood leakage at the arterial cannula luer lock connector, one hour after the ecmo treatment started.It was found that the leakage was occurred from a crack.Customer changed the product with new one.No harm to any person was reported.Complaint # (b)(4).

Manufacturer Narrative

It was reported that a blood leak was occurred at the luer lock connector of hls cannulae due to a crack.The failure was detected after one hour of insert.Customer changed the product during treatment.No harm or death to any person was reported.The sample could not be provided by customer due to china customs regulations.However, a photograph and a video were received which show reported failure ¿crack & leakage¿.Based on this, complaint could be confirmed.The production history record (dhr) of the affected be-pal 1723 with lot# 3000341443 was reviewed on 2024-03-22.According to the dhr results, the product be-pal 1723 passed the defined manufacturing and final release specifications.Further, the incoming inspection report review has been performed for affected component ¿700000285, 00285#konnektor 3/8 x 3/8 ll¿.The incoming inspection report (batch # 3000209523) of the affected component "700000285 / 00285#konnektor 3/8 x 3/8 ll" was reviewed on 2024-03-22.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.The review of the non-conformities has been performed.It does not show any non-conformity in regards to the batch numbers of reported components with related to the reported failure.The exact root cause of the reported failure could not be determined.However, 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 customer will be informed about the investigation results by getinge sales and service unit.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.H3 other text : 4115.

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: 18961027
• MDR Text Key: 338379637
• Report Number: 8010762-2024-00157
• 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: 04/26/2024

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: 3000336023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other