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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS CANNULAE & PIK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH HLS CANNULAE & PIK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-PAL 1923
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2023
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 occurred at arterial cannulae connector.Customer tried to find the reason of the leakage and it was found that the thread of the screw (at connector) was broken and it was impossible to put a cap.Customer changed the connector (which contains the broken thread) of cannulae by cutting the connection.No harm or death to any person was reported.Complaint #(b)(4).
 
Event Description
Complaint #(b)(4).
 
Manufacturer Narrative
It was reported that a leakage was occurred at arterial cannulae connector.Customer tried to find the reason of the leakage and it was found that the thread of the screw (at connector / luer lock) was broken and it was impossible to put a cap.Customer changed the connector (which contains the broken thread) of cannulae by cutting the connection.No harm or death to any person was reported.Additional information was received from getinge representative on 2023-11-16, that - it is unknown how many days the product used on patient before the leakage occurred.- customer made connection to this part, and after the change of the luer lock connector the rest of the cannula is still in use for treatment.- customer changed the position of the patient during care.A photograph was not provided by customer.Further, since customer cut the damaged part to continue to treatment the product lost its integrity therefore a sample was not requested.However, based on the received information, customer needed to change connection of the cannula and cut the damaged part.Therefore, complaint could be confirmed.The production history record (dhr) of the affected be-pal 1923 with lot# 3000319937 was reviewed on 2023-12-04.According to the dhr results, the product be-pal 1923 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Besides, the the failure was occurred on treatment and a crack was not observed / reported before used, therefore production related influences are unlikely.Further, the incoming inspection report (batch # 3000276586) of the affected component "700000285 / 00285#konnektor 3/8 x 3/8 ll" was reviewed on 2023-12-04.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 reported failure could be linked to the risk assessment and control of hls cannulae and the probable causes are associated to: manufacturing: - use of out-of-spec materials user error - lack of attention during device handling: - unintended removal of fem cap from cannula; - mechanical damage of cannula connection during removal of fem cap; - dearing of cannula (tightening luer cap); - damage of cannula connection during connection of tube line; - mechanical damage of cannula during fixation; - disconnection of drainage cannula from tubing line; these root causes could not be confirmed.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 : the product lost its integrity since customer cut the damaged part.
 
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Brand Name
HLS CANNULAE & PIK
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18180440
MDR Text Key328622292
Report Number8010762-2023-00580
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K102532
Number of Events Reported1
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 12/12/2023
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 Model NumberBE-PAL 1923
Device Catalogue Number701047287
Device Lot Number3000319937
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2023
Initial Date FDA Received11/21/2023
Supplement Dates Manufacturer Received12/05/2023
Supplement Dates FDA Received12/12/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2023
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Other;
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