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

Model Number BE-PAL 1923

Device Problem Ejection Problem (4009)

Patient Problem Exsanguination (1841)

Event Date 03/23/2023

Event Type  Injury  

Event Description

It was reported that arterial reperfusion line is disconnected during the patient on intensive care unit.The cannula was inserted on (b)(6) 2023 and the failure occurred on 4th day of usage.Blood loss and unquantified desaturation were occurred on patient.Customer gave 2 unit of blood to make up for lost blood.Trackwise #: (b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.Sample was discarded by user.

Event Description

Trackwise# (b)(4).

Manufacturer Narrative

It was reported that arterial reperfusion line is disconnected during the patient on intensive care unit.The cannula was inserted on (b)(6) 2023 and the failure occurred on 4th day of usage.Blood loss and unquantified desaturation were occurred on patient.Customer gave 2 unit of blood to make up for lost blood.Sample investigation could not be performed since the product was discarded by customer.The customer did not provide the lot number of the affected product.Therefore, dhr (production records) review could not be performed.Getinge medical affairs conducted a medical review: the event details are described as: ¿a 53 year old patient was treated for an acute coronary syndrome by angioplasty and subsequent stenting.The treatment was complicated by cardiac arrest which required resuscitation via veno-arterial (va)ecmo.Arterial cannula was placed in the left femoral arterial, however no details were provided about placement.On (b)(6) 2023 (around 0430 hrs), it was discovered by nursing services that the arterial cannula was disconnected.The information of whether the arterial cannula disconnected from arterial tubing line or the arterial cannula became disconnected / dislodged from arterial site in the patient were not provided by customer.Further, it was stated by the customer that mobilization (i.E.Movement / repositioning) of the patient was not performed in the course of care (i.E.Up to the time of the event).It is assumed that the patient was clinically stabilized after the administration of the two (2) units of prbcs.Supplementary fluids are assumed to have been administered (along with the prbcs) to aid in volume replenishment of the patient.¿ the related mitigations were stated within this review and are in place in the hls cannulae ifu (instruction for use): - caution! if the cannula is not inserted up to the limit stop, it must be fixed in an appropriate way.- caution! attach the cannula securely to the vessel or surrounding tissue to prevent accidental dislocation during the extracorporeal circulation.- caution! if a suture is directly looped around the wire-reinforced section, the cannula can be cut into, kinked or damaged.Secure the cannula around the rigid barbed connectors in such a way as to ensure that it is not kinked at the insertion site.Attach the cannula securely to the vessel.For this purpose, use the removable skin attachment accessory supplied or else a slit at the end of the cannula for the suture material.The removable skin attachment accessory has holes to take the suture material.- caution! check the connection between cannula and tubing set regularly.H3 other text : sample was discarded by customer.

• Brand Name: CANNULA & CATHETER
• 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: 16712509
• MDR Text Key: 313014546
• Report Number: 3008355164-2023-00015
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K10532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-PAL 1923
• Device Catalogue Number: 701047287
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2023
• Distributor Facility Aware Date: 05/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other