MAUDE Adverse Event Report: SURGE CARDIOVASCULAR/MED MICHIGAN HOLDINGS LLC ALPINE 20FRENCH FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 06691-041823

Device Problems Break (1069); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  Injury  

Event Description

Patient cannulated with alpine 20french femoral venous cannula for use in ecmo.Staff noted decreased flows while on ecmo.Provider de-cannulated patient approximately 3.5hrs after initial cannulation and removed 20french cannula from left femoral vein noting it to be fractured in half.Patient was re-cannulated without issue.On (b)(6) 2023, patient was again de-cannulated due to decreased flows.This time a 24french cannula was removed from the right femoral vein and noted to be fractured in half.No harm to patient either time.Reference report: mw5118501.

• Brand Name: ALPINE 20FRENCH FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SURGE CARDIOVASCULAR/MED MICHIGAN HOLDINGS LLC; wilkes-barre PA 18702
• MDR Report Key: 17182273
• MDR Text Key: 317791698
• Report Number: MW5118502
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 06691-041823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American