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

Model Number BE-PAL 1723#

Device Problem Crack (1135)

Patient Problem Bradycardia (1751)

Event Date 07/03/2023

Event Type  Death  

Event Description

Our qa colleague saw a be-pas (l) 1723 complaint reported by (b)(6) memorial hospital of (b)(6) university on china national medical device adverse event monitoring information system.Complaint #(b)(4) was created in order to investigate the issue.The event was described by the customer as below: "blood leakage noticed on the connection of the arterial cannula be-pal 1723 while the clinicians changed the treatment from v-a ecmo to v-a-v ecmo.They stopped the pump and replaced a new cannula and continued run the ecmo treatment.During the period, the patient experienced a decrease in heart rate from 104 beats/min to 60 beats/min, and blood pressure as low as 45/20 mmhg, requiring the use of intravenous epinephrine pump treatment.".Complaint #: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Getinge representative informed the manufacturer on 2023-07-31 that the patient expired.A follow-up medwatch will be submitted when further information becomes available.H3 other text : 4115.

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported by the customer to the authority that blood leakage noticed on the connection of the arterial cannula be-pal 1723 while the clinicians changed the treatment from v-a ecmo to v-a-v ecmo.They stopped the pump and replaced a new cannula and continued run the ecmo treatment.During the period, the patient experienced a decrease in heart rate from 104 beats/min to 60 beats/min, and blood pressure as low as 45/20 mmhg, requiring the use of intravenous epinephrine pump treatment.On july 31, 2023 getinge representative informed manufacturer that the patient died.The customer was not able to provide additional information in regards to the death of the patient.The sample investigation could not be performed since the sample could not be provided due to the chinese customs restrictions and regulations.A photograph was received from customer however, that does not clearly show the failure.There was no visible damages can be observed.It was reported that the blood leakage noticed at the connection of the luer lock to the cannula.The production history record (dhr) of the affected be-pal 1723# with lot # 3000276943 was reviewed on 2023-08-18.According to the dhr results, the product be-pal 1723# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Medical review has been performed by medical affairs team in order to assess the event and determine the possible causes.Medical review has been finalized on 2023-09-15 based on the available data and information.According to this review: "as the cannula could not be examined by getinge life cycle engineering and the lack of descriptive information in the complaint, a definitive root cause could not be established.After evaluation of the data provided by the customer, the leakage at the luer-port may have been attributed to the following possible causes: it is possible, that the luer-cap was askew after de-airing, which might have led to damage of the luer-threading or have introduced a fissure into the rigid material structure of the connector.A fissure may have been present in the connector prior to use, resulting in leakage under pressure of ecc(extracorporeal circulation)-flow.The luer-connector could be damaged by manipulation during the cannulation procedure, for example when connecting a pressure line for placement verification.The use of this technique was not explicitly stated by the customer, but may have been excluded from the report.The connector may have been compressed and, thus, damaged by a tubing clamp during cannulation or during modification of the ecc-circuit.It is unclear what/if other components were attached to the cannula luer connection.If other components were attached (e.G., stopcock), a higher profile may have been created, allowing snagging of the added component and the luer connection on other materials (e.G., blankets, cables, bed frame, etc.).It is unclear whether the cannula/connector was damaged prior to use, during insertion, or sometime during the procedure.The attendant warnings and precautions regarding product use are part of hls cannulae ifu (instruction for use): ifu hls cannulae set, g-139, v05 page 9: "failure to comply with the intended use can result in serious injuries or death.¿ only use the device in accordance with these instructions for use.¿ read the instructions for use completely before using the device.¿ observe all information on the device.¿ also follow the instructions for use for additional components used.A lack of knowledge on use of the device can result in serious injuries or death.¿ the device must only be used by an experienced physician.¿ the physician in charge of treatment is responsible for the procedure and correct use of the device.The use of non-sterile or defective devices can result in infection of the patient, user and third parties.¿ only use the device if it is sterile.¿ do not use the device if it or the sterile packaging is damaged.¿ observe the use-by date on the packaging.¿ always observe strict asepsis when handling the device.Modifications to the device can result in serious injuries to or death of the patient.¿ do not modify the device." if the dead-ending cap was, indeed, one of the possible root causes, it is recommended to assure the proper seating/securement of the cap to the luer connection: ifu hls cannulae set, g-139, v05 page 11: "caution! if you use the arterial cannula, check the luer lock caps are secure before use." given the nature of ventricular failure after heart-transplantation and the necessity of escalation to v-av support from va ecmo it seems that the negative outcome (patient expiration) may most likely be related to the status of the patient, opposed to the product itself.There is no indication of a correlation between the outcome of the patient and the event described in the complaint narrative (i.E.Leaking cannula luer).Further, no association with the event explained in the complaint and a decrease in product performance can be ascertained from the information provided in the complaint." the information obtained so far in this investigation is not sufficient to confirm the product failure.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 trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint #: (b)(4).

• 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: 17349763
• MDR Text Key: 319290570
• Report Number: 3008355164-2023-00025
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

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 1723#
• Device Catalogue Number: 701047286
• Device Lot Number: 3000276943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2023
• Distributor Facility Aware Date: 09/15/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2023
• Supplement Dates Manufacturer Received: 07/31/2023; 09/15/2023
• Supplement Dates FDA Received: 08/01/2023; 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male