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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CB511
Device Problem Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/24/2021
Event Type  Injury  
Manufacturer Narrative
Medtronic investigation: the information provided indicated the leak did not occur until well after the devices 6 hour use indication. Under this guidance, the fda is allowing temporary limited modifications to the indications of certain fda-cleared or fda-approved cardiopulmonary devices without prior submission of premarket notification. These modifications are allowed, in light of the public health emergency, when they do not create an undue risk. This indication modification is in effect for the duration of the public health emergency related to covid-19, as declared by the department of health and human services (hhs). Temporary limited modifications to the indication: "in accordance with the fda guidance, the devices listed have a modified indication for use during the covid-19 public health emergency. This indication modification has not been cleared or approved by the fda, but shall apply temporarily to the device models listed in this supplement: the device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ecmo) circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure. " it is likely the prolonged used contributed; however, medtronic cannot confirm or deny if the length of the procedure contributed to the reported inci dent. No device was returned for analysis, so a root cause cannot be determined, but pictures were provided that confirm the report. Pict ures provided indicate a 'white' foam from the fiber bundling indicating protein breakthrough occurred. Affinity nt oxygenator fiber/plasma leaks are an extremely low occurring phenomena with devices made with microporous membrane. The product is designed to maximize the performance and robustness of the oxygenator and medtronic uses extremely sophisticated techniques for identifying leaks in the production process. As the device was not returned and no valid serial number was provided, a dhr review was not possible. This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary. Trends for issues with this product are reviewed at quarterly quality meetings. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the customer reported the custom pack's fusion oxygenator was oozing blood and there were a lot of bubbles on the outside of the device. 200ml of blood was lost per hour, and a blood supplement was needed to maintain capacity. The total blood loss (ml) due to leakage was about 800ml. The device was replaced. There was no adverse effect to the patient. Additional information: ecmo assistance was carried out on january 21 until a leak was found on the 24th, a total of 3 days. There was no damage to the device, the packaging or other contents within the package. There was no visible air in the system/tubing.
 
Manufacturer Narrative
Correction to b5: "the customer reported the custom pack's affinity nt oxygenator was oozing blood". Previously reported incorrectly as a "fusion oxygenator". If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the customer reported the custom pack's affinity nt oxygenator was oozing blood and there were a lot of bubbles on the outside of the device. 200ml of blood was lost per hour, and a blood supplement was needed to maintain capacity. The total blood loss (ml) due to leakage was about 800ml. The device was replaced. There was no adverse effect to the patient. Additional information: ecmo assistance was carried out on january 21 until a leak was found on the 24th, a total of 3 days. There was no damage to the device, the packaging or other contents within the package. There was no visible air in the system/tubing.
 
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Brand NameCARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer (Section G)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11391325
MDR Text Key244381476
Report Number2184009-2021-00008
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K191029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCB511
Device Catalogue NumberCB511
Device Lot Number219741208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/01/2021 Patient Sequence Number: 1
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