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

Model Number HLS CANNULA + PIK

Device Problem Leak/Splash (1354)

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

Event Date 02/07/2024

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 on hls cannulae after insert.Customer changed the product during treatment.No harm to any person was reported.More information has been requested from getinge representative.Complaint # (b)(4).

Manufacturer Narrative

The clinicians noticed that the blood jetting from the cannula be-pal 1723 after it was inserted soon.Customer changed the product with new one.No harm to any person was reported.The sample could not be provided due to china customs regulations.A video was received which shows the leakage at the connection between connector and cannulae body, based on this failure could be confirmed.The production history record (dhr) of the affected be-pal 1723 with lot# 3000321037 was reviewed on 2024-03-04.According to the dhr results, the product be-pal 1723 passed the defined manufacturing and final release specifications.Further, the incoming inspection report (batch # 3000276586) of the affected component "700000285 / 00285#konnektor 3/8 x 3/8 ll" was reviewed on 2024-03-04.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 incoming inspection report (batches #3000313001, 3000313003, 3000313008, 3000313009, 3000313012, 3000313013) of the affected component " 701046340 / fem body17_al-01#peri.Cath.Body 17fr, al" was also reviewed on 2024-03-04.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 non-conformity record review was performed and there could not be found any non-conformity that could cause to reported failure.Besides, the maintenance records of the used work equipments (heavy duty tube inserter machine & manual fitting inserter machine) were checked via sap for the dates between 2023-05-07 & 2023-07-07.There could not be found any non-conformities that could cause to reported failure.Exact root cause could not be determined.However, the reported failure could be linked to the risk assessment file of product and probable causes have been identified as: user error -lack of attention during device handling: mechanical damage of cannula connection during removal of fem cap.Damage of cannula connection during connection of tube line.Mechanical damage of cannula during fixation.Manufacturing: use of wrong or out-of-spec materials due to lack of attention.Transport / storage: mechanical damage of the product due to vibration and impact during transportation and storage.Production employees were informed about the complaint # (b)(4) on 2024-02-28 to increase awareness.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: 18694172
• MDR Text Key: 335996225
• Report Number: 8010762-2024-00083
• 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: 03/19/2024

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: HLS CANNULA + PIK
• Device Catalogue Number: BE-PAL 1723
• Device Lot Number: 3000321037
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other