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

Model Number BE-PAL 1723#

Device Problem Fluid/Blood Leak (1250)

Patient Problems Respiratory Insufficiency (4462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported that the patient had lung infection and the diagnosis of septic shock was confirmed.At that time, the patient was breathing with the aid of ventilator, fio2 100%, oxygen saturation could not be maintained, continuous crrt was used to correct the acidosis, and large doses of norepinephrine, epinephrine, and pituitrin were pumped, but the blood pressure was still low.After communication with the patient's family, ecmo treatment was given at 16:00 on (b)(6) 2022.At 17:00 on (b)(6) 2022, it was found that the connection between the ecmo tube and the three-way stopcock connection was leaking, resulting in blood bleeding.The clinician concerned about infection risk.The patient was weaned from rotaflow system at 19:00 on (b)(6) 2022.However, the patient's heart and lung functions were not fully recovered and the length of hospital stay and cost of the patient were increased.The customer did not replace the set or the stopcock during use till they stopped ecmo treatment.No harm to any person has been reported.Complaint #: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

The complaint was found from china national medical product administration website on 2022-12-06.The customer did not report to maquet.It was reported that the patient had lung infection and the diagnosis of septic shock was confirmed.At that time, the patient was breathing with the aid of ventilator, fio2 100%, oxygen saturation could not be maintained, continuous crrt was used to correct the acidosis, and large doses of norepinephrine, epinephrine, and pituitrin were pumped, but the blood pressure was still low.After communication with the patient's family, ecmo treatment was given at 16:00 on (b)(6) 2022.At 17:00 on (b)(6) 2022, it was found that the connection between the ecmo tube and the three-way stopcock connection was leaking, resulting in blood bleeding.The clinician concerned about infection risk.The patient was weaned from rotaflow system at 19:00 on (b)(6) 2022.However, the patient's heart and lung functions were not fully recovered and the length of hospital stay and cost of the patient were increased.Addition information has been received on 2022-12-08 provided by the ssu that the customer did not replace the set or the stopcock during use till they stopped ecmo treatment.No harm to any person has been reported.The sample is not available because china custom does not allow ship contaminated medical devices.The production history record (dhr) of the affected be-pal 1723# with lot#3000200301 was reviewed.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.Thus production related influences are unlikely.Further the incoming inspection reports of the affected components "700000285 00285#konnektor 3/8 x 3/8 ll" and ¿701046340 fem body17_al-01#peri.Cath.Body 17fr, al¿ were reviewed.The products were checked for scratches, ridges, sharp edges, cracks, and streaks visually.All tests were passed as per specifications.Getinge medical affairs performed a medical assessment as follows: the reported event was carefully reviewed based on the available information received in the customer product complaint report, the limited correspondence describing the event, and the appended video received.No investigation report on the associated disposables could be conducted, as the disposables were not recovered.It is notable the cannulae, luer fitting and stopcock combination were not reportedly leaking for the duration of application from (b)(6) 2022 to (b)(6) 2022 at 1700 hours.The extracorporeal circuit was primed and therapy initiated.The integrity of the circuit, the cannulae and connections were presumably intact until the leak was noted during routine care and inspection on (b)(6) 2022.There were no reported issues with the package integrity or the disposable during the pre-insertion, insertion and application until the event was reported.A review of the video appears to localize the leak around the 3/8.3/8 connector as opposed to the luer fitting as reported.However, a review of video alone can be misleading as blood may be tracking along the tubing and dripping proximal to the luer to 3/8 inch connection.Without direct analysis/visualization of all the components it is not possible to conclude which component was damage and then link this finding to an associated cause.The following possible causes of an ecc leak are only suggested based on limited information and assessment: - a stress fracture on the 3/8:3/8 connector - a stress fracture on the 3 way stopcock (over-tightening/patient repositioning) - cross threaded luer to 3/8 inch connection - a pin hole in the tubing - a damaged 3/8 connector to 3/8 inch tubing connection - mal-fitting tubing to 3/8 inch connection.- mal-positioning of the tie bands at the tubing-connector juncture - inappropriately tightened tie bands at the tubing-connector juncture the proposed above mechanisms responsible for a leak appear to have occurred at some point following initiation of therapy on (b)(6) 2022.The most plausible cause(s) based on frequency of occurrence is suggested to be a fracture of the stopcock/luer fitting during application.This is only a suggestion and does not exclude other mechanisms responsible for leakage.The component failure responsible for the leak (and the mechanism) cannot be conclusively identified.Limited blood loss appears to have occurred based on a review of the video.The medical staff elected to discontinue therapy 2 hours after the observed leak and five days into treatment due to the potential infection risk.The decision to discontinue therapy (as opposed to replacing the cannulae and/or stopcock and resume therapy) is exclusively based on the clinical assessment and judgement of the attending physician.No association between the length of hospitalization and recovery can be drawn retrospectively based on the clinical management decisions that were made, and the available information provided in the complaint report and correspondence.In terms of possible use errors, extreme care and vigilance must be exercised with all cannulae, luer connections and tubing connections during insertion, initiation and application of therapy.All components of the extracorporeal circuit should be routinely assessed for integrity during application and changed out as required based on the clinical management of the patient.The clinical team appeared to be vigilant and addressed the event irrespective of the root cause.As a result, patient harm appeared to be limited.The customer will be informed about the investigation results via getinge sales and service unit.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

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: 16031946
• MDR Text Key: 306496973
• Report Number: 8010762-2022-00512
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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 Expiration Date: 10/22/2023
• Device Model Number: BE-PAL 1723#
• Device Catalogue Number: 701047286
• Device Lot Number: 3000229254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female