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

Model Number BE-PAS 1715 -J#BE-HLS CANNULA 17F AS

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 04/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that hls cannulae was inserted for blood transfusion and ecmo was started.After 10 hours of treatment, the 6mm port cap came off.Leakage was occurred through the port.It is unknown at this moment if any harm was occurred on patient.Trackwise #(b)(4).

Manufacturer Narrative

It was reported that hls cannulae was inserted for blood transfusion and ecmo was started.After 10 hours of treatment, the 6mm port cap came off.Leakage was occurred through the port.It is unknown at this moment if any harm was occurred on patient.Sample investigation could not be performed since the product was discarded by customer.Further information was not received from customer like flow rate, any abnormalities before use however it was stated that it could not be confirmed if the cap was securely closed.Besides, the reported failure was occurred after 10 hours of usage therefore it could be concluded that there was not any failure that detected during visual controls.Customer did not provide the lot number of the affected product.Therefore, dhr (production records) review could not be performed.Further, the affected materials are determined as (b)(6) konnektor 3/8 x 3/8 ll and (b)(6) #llm-cap non vented by complaint description.Review of the non-conformities has been performed.It does not show any non-conformity in regards to the reported product and failure.The exact root cause could not be determined however the reported failure could be linked to the risk assessment and control of hls cannulae and the most probable cause could be: use errors: lack of attention on device handling.Based on the investigation results, the failure could be confirmed however not product related.The related mitigations are in place instruction for use of the device: ifu information: avoid subjecting the cannula to mechanical loads.Ifu information: 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.Ifu caution! if you use the arterial cannula, check the luer lock caps are secure before use.The customer will be informed by getinge sales and service unit about the investigation results.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

(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: 16990280
• MDR Text Key: 316474084
• Report Number: 8010762-2023-00235
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-PAS 1715 -J#BE-HLS CANNULA 17F AS
• Device Catalogue Number: 701067486
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1