MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96830-112

Device Problem Use of Device Problem (1670)

Patient Problem Hemolysis (1886)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

The date this paper was presented at the 13th annual international meeting of the pediatric cardiac intensive care society has been used as the event date.Literature title of the article:bivalirudin anticoagulation for an infant with hyperbilirubinemia and elevated plasma-free hemoglobin on ecmo.Authors: chidiebere ezetendu, angela jarden, mohammed hamzah and robert stewart journal name:the journal of extracorporeal technology year: 2019.Issue: 51 reference:extra corpor technol.2019;51:26¿8.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding bivalirudin anticoagulation for an infant with hyperbilirubinemia and elevated plasma-free hemoglobin on extracorporeal membrane oxygenation (ecmo).The article outlines a venous arterial (va)-ecmo case for a two-month-old full-term unimmunized male that was admitted to intensive care with respiratory syncytial virus bronchiolitis and respiratory distress.The venous arterial (va)-ecmo system contained cannulae from medtronic (model and lot numbers not provided).Thirty-five hours after ecmo cannulation, anticoagulation was changed to bivalirudin with a starting dose of.3 mg/kg/h.The first aptt level, 4 hours after initiation, was 96 seconds.Bivalirudin was titrated to achieve target aptt goals and values of 60¿80 seconds were consistently achieved, starting 11 hours after switching to bivalirudin and throughout the remainder of the patients¿ ecmo course.Anticoagulation during this period was reliably achieved with bivalirudin, even in the presence of high bilirubin and plasma-free hemoglobin levels.Ultimately, the underlying cause of hemolysis was identified as cannula malposition with very high ecmo negative inlet pressure after bedside venous cannula manipulation resulted in a dramatic decrease in negative inlet pressure.Following the cannula adjustment, the hemolysis resolved on day 4.The patient¿s clinical condition improved, and he was successfully decannulated after 5 days on ecmo.No additional adverse patient effects were reported.

• Brand Name: BIO-MEDICUS FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9878934
• MDR Text Key: 190334071
• Report Number: 2184009-2020-00019
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/25/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 96830-112
• Device Catalogue Number: 96830-112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO