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 12/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a leakage was detected at the luer connector of hls cannulae.The failure was occurred on after 3 days of insert.No harm to any person was reported.Complaint # (b)(4).

Manufacturer Narrative

It was reported that a leakage was detected at the luer connector of hls cannulae.The failure was occurred on after 3 days of insert.Customer changed the product during treatment.No harm or death to any person was reported.Additional information was received from getinge representative on 2024-01-04.Information is as below: there was not any defect detected on the product before use.Customer said that completed visual inspection carefully before use.Customer did not use any cleaning agent on the product.The product was changed in time therefore there was not any harm for patient.The sample investigation could not be performed since the product could not be provided due to china custom regulations.A photograph was provided by customer which shows the crack at the luer lock connector of hls cannulae.Based on this, failure could be confirmed but not product related.The production history record (dhr) of the affected be-pal 1723 with lot# 3000290394 was reviewed on 2024-01-05.According to the dhr results, the product be-pal 1723 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 third day of usage.Thus, production related influences are unlikely.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 # 3000232244) of the affected component "700000285 / 00285#konnektor 3/8 x 3/8 ll" was reviewed on 2024-01-05.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 reported failure has been consulted to life cycle engineer on 2024-01-08 with provided photographs of the complaint.Received information from life cycle engineer states that: ¿the correct position of the fem clamp is shown in the ifu as at the bottom of the connector of hls cannulae.However, in the provided photographs, it is clearly visible that the fem clamp was on the connector.At this position of the fem clamp, luer lock connector could be easily cracked with a little bit force during treatment (like changing position of the patient).¿ based on the received information and investigation results, the exact root cause could not be determined.However, the reported failure could be caused by the wrong fem clamp position.Besides, ifu mitigates the reported failure as follow: ifu, hls cannulae, g-139, v05, page 10 ¿5.3 safety instructions for cannulae¿: avoid subjecting the cannula to mechanical loads.If the patient is repositioned or transported, there is a risk of decannulation caused by strain on the tubing and mechanical damage.The greatest care should therefore be exercised when carrying out these measures.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: 18441824
• MDR Text Key: 331864183
• Report Number: 8010762-2024-00010
• 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: 01/24/2024

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: 3000290394
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other