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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HFO CARMEDA COATED OXYGENATOR, CARDIOPULMONARY BYPASS

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PERFUSION SYSTEMS FUSION HFO CARMEDA COATED OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CB811
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of a fusion oxygenator, the customer reported that greatly elevated pressure occurred in the circuit (pre-oxygenator pressure) rapidly after about 5-7 min of the cpb. After checking the arterial cannula and circuit, an additional pressure was applied to the circuit (post-oxygenator pressure), which confirmed that a high pressure drop in the oxygenator has occurred. The problem was isolated to the oxygenator. Treatment with nitroprusside was started as treatment for the high blood pressure according to routine, but the high pressure drop persisted. Then was decided that the oxygenator needed to be replaced. Ecc was terminated, the oxygenator was changed as usual. During the oxygenator exchange, the patient had their own adequate circulation, and before exchange the cpb was stopped. Directly after the exchange, the cpb was started again. Ecc was started immediately after the change-out.  there was no patient impact associated with this event. Additional information: for about 10-15 minutes, the perfusion from the heart-lung machine could not deliver full flow. Throughout the process, the patient had their own supporting circulation. The prime volume was 1400ml of ringer-acetat with 10 000iu/heparin. Standard anesthesia drugs were used during the case. And nitroprusside when the pressure drop occurred. Initial pre oxygenator pressure was measured, and after the increased pressure, post oxygenator was also measured. The heparin dosing calculation was 400iu/kg, and act is aimed to 480sec. After bolus dose (45 000iu) the act was 494. After 5 min cpb it was 580 sec. Before oxygenator exchange another 10000iu was given, and after exchange the act was 1000sec. The temperatures pre and post oxygenator were as follows: pre oxy temp 34. 8c. Post oxy temp 34. 1c.
 
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Brand NameFUSION HFO CARMEDA COATED
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 Key12770425
MDR Text Key280458446
Report Number2184009-2021-00108
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K183490
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberCB811
Device Catalogue NumberCB811
Device Lot Number221398139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2021
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: 11/08/2021 Patient Sequence Number: 1
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