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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-PVL 2355-USA
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2022
Event Type  malfunction  
Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that the knob (handle) on the top of the introducer broke.It was detected after inserting the cannula, the surgeon tried to take out the introducer.They had to use clamps to pull the introducer out.No harm or death to any person was reported.Complaint #: (b)(4).
 
Manufacturer Narrative
It was reported that the knob (handle) on the top of the introducer broke.It was detected after inserting the cannula, the surgeon tried to take out the introducer.They had to use clamps to pull the introducer out.No harm or death to any person was reported.The product was received however declaration of infection risk (doir) was missing.According to complaint sample investigation procedure the declaration of infection risk must always be included in potentially infectious samples.Without doir, the product pack cannot be opened due to safety issues.The doir was requested from customer on 2022-12-30.The reminders were sent respectively on 2023-01-12, 2023-01-20 and 2023-01-25.There is no response received from the customer.Therefore, the sample could not be investigated in the laboratory of manufacturer.Beside, there is not any image shows the failure.The production history record (dhr) of the affected beq-pvl 2355-usa with lot# 3000207063 was reviewed.According to the dhr results, the product beq-pvl 2355-usa passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The review of the non-conformities has been performed.It does not show any non-conformity in regards to the batch numbers of reported components and failure.The exact cause of the failure could not be determined.The reported failure was identified as part of the current risk management file (dms#3186956, v01) and the most probable causes are associated to: 1.Manufacturing: - inappropriate assembly of components 2.Logistics: - mechanical damage of product due to vibration and impact during transport and storage - loosening of handle from introducer due to vibration and impact during transport and storage 3.User: - loosening of handle from introducer during insertion of introducer into cannula due to mechanical loads due to the fact that the customer had to use clamps to pull the introducer out, the complaint could 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.
 
Event Description
(b)(4).
 
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Brand Name
CANNULA & CATHETER
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 Key15852963
MDR Text Key304199666
Report Number8010762-2022-00467
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2023
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 Date11/24/2023
Device Model NumberBEQ-PVL 2355-USA
Device Catalogue Number701053092
Device Lot Number3000207063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2022
Initial Date FDA Received11/23/2022
Supplement Dates Manufacturer Received02/01/2023
Supplement Dates FDA Received02/16/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/24/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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