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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-PVL 2555#BE-HLS CANNULA 25F VL
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2023
Event Type  malfunction  
Manufacturer Narrative
It was reported that the hand (griff) of the introducer came off when the hls cannulae was percutaneously inserted and the introducer was removed.Surgery was completed as using new hls cannulae.There was not any impact on patient.No harm to any person has been reported.The sample was discarded by customer therefore laboratory investigation could not be performed.The reported failure caused the customer to change hls cannula with a new one.Based on that the failure could be confirmed.The production history record (dhr) of the affected be-pvl 2555 with lot# 3000256275 was reviewed on 2023-06-12.According to the dhr result, the product be-pvl 2555 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.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.Further, the incoming inspection reports of the affected components griff (handle) (batch # 3000199908) and introducer (batch # 3000237279) were reviewed on 2023-06-12.The griff (handle) was checked visually for particles, pressure marks, rills, streaks, sinks, fat, dirt, blur, cords, scratches, burrs, bubbles and also measured for diameter (inner).The introducer was checked visually for ridges, sharp edges, cracks, streaks, dirt, spots, bubbles and also measured for diameter (outer).All tests were passed as per specifications.The reported failure was identified as part of the current risk management file 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 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: 4115.
 
Event Description
It was reported that the hand (griff) of the introducer came off when the hls cannulae was percutaneously inserted and the introducer was removed.Surgery was completed as using new hls cannulae.There was not any impact on patient.No harm to any person was reported.Complaint # (b)(4).
 
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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
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key17125408
MDR Text Key317845243
Report Number8010762-2023-00290
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 06/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date07/18/2022
Device Model NumberBE-PVL 2555#BE-HLS CANNULA 25F VL
Device Catalogue Number701047296
Device Lot Number3000256275
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient SexMale
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