MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS PED. FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	96830-008
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection of the returned product indicated evidence of cuts/damage along the body of the cannula.Additional visual inspection showed damage toward the tip of the device, potentially from a hemostat.During the cleaning process there was a leak observed from the cannula.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during cannulation using a bio-medicus pediatric venous cannula, air was entering into the ecmo line/circuit, generating at what the customer believed was the cannula.The patient had to come off bypass/ecmo to change the cannula out.During that time they were off bypass, the patient received chest compressions, several rounds of epinephrine and calcium gluconate to maintain pressure.Once the cannula was replaced, there were no further issues with air entering the circuit and the ecmo run continued uneventfully.There was no adverse effect to the patient.

• Brand Name: BIOMEDICUS PED. FEMORAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 7989199
• Report Number: 2184009-2018-00033
• Device Sequence Number: 1255063
• Product Code: DWF
• UDI-Device Identifier: 00613994530783
• UDI-Public: 00613994530783
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K872033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 96830-008
• Device Catalogue Number: 96830-008
• Device Lot Number: 2015120671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 DA
• Patient Weight: 2