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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 HLS CANNULA
Device Problems Crack (1135); Free or Unrestricted Flow (2945)
Patient Problem Cardiac Arrest (1762)
Event Type  Death  
Manufacturer Narrative
Investigation is ongoing.A follow-up medwatch will be sent when further information becomes available.
 
Event Description
It was reported that a hls venous cannula connector cracked while inserted within a patient for approximately 55 days.Customer advised that the patient was turned by hospital staff and when this occurred the connector cracked.He advised that when the connector cracked the circuit entrained air and the pump stopped.He advised that pressure was applied to the cannula site but that the patient was bleed through the crack in the cannula.Patient expired.Complaint: # (b)(4).
 
Event Description
Complaint: (b)(4).
 
Manufacturer Narrative
It was reported that a hls venous cannula connector cracked while inserted within a patient for approximately 55 days.Customer advised that the patient was turned by hospital staff and when this occurred the connector cracked.He advised that when the connector cracked the circuit entrained air and the pump stopped.He advised that pressure was applied to the cannula site but that the patient was bleed through the crack in the cannula.Patient expired.Maquet cardiopulmonary requested the product back for investigation in the laboratory of manufacturer.The product is not available for investigation as it was discarded by the customer.The relevant information (product information, event details and relation with the maquet device) was requested on 2021-04-21.The information was received on 2021-06-08.The medical review shows, the expiration of the patient appears to be directly related to an inadvertent mishandling of the product during turning/repositioning of the patient rather than to an inherent defect or malfunction of the product, per se.It is likely that extraordinary stress and/or torque was inadvertently applied to the cannula during the turning maneuver, resulting in a fracture of the cannula.Stress and/or torque to the cannula also may have been exacerbated through repeated turning (repositioning) of the patient over the period of 55 days, i.E.If multiple occasions of repositioning/turning occurred.The hls cannula instructions for use states the intended use period for the product is 6 hours (instructions for use catheters & cannulae hls cannulae set g-639 70105.3080).It is challenging to discern if the dwell time of 55 days influenced the structural integrity of the cannula (i.E.Through long term heat exposure, repeated torque/stress, cannula repositioning, etc.); as the verification tests of the cannulae are performed to cover the maximum application time of 30 days.Moreover, there was no indication from the complaint narrative of any diminution of, or negative influence on, structural integrity or performance.Moreover, the expiration of the patient appears to be directly related to an inadvertent mishandling of the product during turning/repositioning of the patient rather than to an inherent defect or malfunction of the product, per se.The cause of the reported failure could be associated with the manipulation and/or positioning of the patient during support with cannulae in situ.Based on this information, the cause of the event could not be attributed to the device.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.
 
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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
MDR Report Key11694058
MDR Text Key246272756
Report Number3008355164-2021-00012
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
K102532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/12/2021
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 NumberHLS CANNULA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2021
Distributor Facility Aware Date06/25/2021
Event Location Hospital
Date Report to Manufacturer07/12/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/20/2021
Supplement Dates Manufacturer Received06/25/2021
Supplement Dates FDA Received07/12/2021
Patient Sequence Number1
Patient Outcome(s) Death;
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