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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS

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EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number US5062
Device Problem Mechanical Problem (1384)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 01/07/2021
Event Type  Injury  
Event Description
Related manufacturer¿s report #3003306248-2021-00009. It was reported that the patient had blood loss anemia. Due to this, the patient was transfused with 6 units of reagent red blood cells, 3 units of fresh frozen plasma, 2 units of platelets and 20 cryo intraoperatively. The patient's chest was left open and the patient was brought back to the operating room for chest closure on (b)(6) 2021. The patient also had renal dysfunction with acute kidney injury post operation. The patient was placed on continuous renal replacement therapy (crrt). The patient had their arterial extracorporeal membrane oxygenation (ecmo) cannula in the right femoral artery with distal reperfusion catheter in place. The patient arrived to the intensive care unit (icu) with mottled right foot, unable to obtain pedal pulses. Popliteal pulses present. On (b)(6) 2021 the patient was taken back to the operating room for removal of ecmo cannulation from right iliofemoral arteries, thrombectomy of right common femoral, proximal profunda, superficial femoral and popliteal arteries and four compartment of fasciotomies of right calf. The patient had their chest closed on (b)(6) 2021. The patient had combined blood loss anemia from cardiac surgeries and additional surgeries requiring vascular surgery to lower extremity and laparotomy. The patient had worsening hemodynamic decompensation. A ct scan was obtained showing free intraperitoneal air concerning for bowel ischemia. The patient was taken of an emergent laparotomy. The patient had an infarction of the majority of the small bowel and right colon, which was resected and left in discontinuity for a second look surgery planned for (b)(6) 2021. A ct scan showed patency of the superior mesenteric artery out to the distal branching, then becomes difficult to visualize branches. Also showed an embolization to the liver and kidneys suggestive of a diffuse embolic event. This patient appears to have suffered a combined embolic and low flow insult to the bowel. The patient had acute liver injury related to shock versus ischemic damage with right hemiliver infarct noted on the ct. Liver enzymes and the patient's inr remained elevated despite the fresh frozen plasma administration. The patient was on antibiotic therapy due to positive bacterial blood cultures and endocarditis preoperatively. The patient was taken for a laparotomy on (b)(6) 2021. Peritoneal fluid grew candida albicans and 1 of 2 blood culture bottles also grew candida albicans. The patient started on antigungal therapy. The patient had repeat cultures drawn on (b)(6) 2021. The patient was taken back to the operating room on (b)(6) 2021 for extended ileostomy. The patient was taken back to the operating room on( b)(6) 2021 for re-exploratory laparotomy, ileostomy creation and cholecystostomy tube placement. On (b)(6) 2021 the patient experienced bleeding from oropharyngeal site, ears, nose and throat specialist was consulted and packing was placed. As of (b)(6) 2021, the patient received a total of 32 units of red blood cells and 13 units of platelets since initial surgery. During the initial surgery the patient had respiratory and metabolic acidosis and was placed on veno-venous (vv) ecmo and converted to veno-veno-arterial (vv-a) ecmo prior to leaving the operating room. The patient was unable to be extubated due to elevated inr tracheostomy was not placed. On (b)(6) 2021 the patient was taken to the operating room for ecmo conversion from veno-arterial (va) ecmo to vv ecmo. The patient required some respiratory support with carbon dioxide elimination. There was also a clot noted in the top perimeter of the oxygenator.
 
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Brand NameADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
EUROSETS S.R.L.
strada statale 12, n°143
medolla, modena 41036
IT 41036
Manufacturer (Section G)
EUROSETS S.R.L.
strada statale 12, n°143
medolla, modena 41036
IT 41036
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key11293930
MDR Text Key234407586
Report Number3003752502-2021-00003
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS5062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/08/2021 Patient Sequence Number: 1
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