MAUDE Adverse Event Report: MEDTRONIC, INC. BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 2016120609

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  Injury  

Event Description

Reports of some acceptable oozing from cannula sites during the night with stable hemoglobin and hematocrit (h/h), arterial blood gas (abgs), and hemodynamics within acceptable parameters.On-coming rn performing assessment noticed a large amount of blood on pillow and around neck.Immediately called for help and then, almost simultaneously, the extracorporeal membrane oxygenation (ecmo) console alarmed and circuit clamped.Cannula noted to be partially dislodged it had been sutured with 3 sutures and they were noted to be still intact on skin and around cannula, but cannula had slipped through.Flows through circuit were previously running at 4 l/min.Surgeon at bedside within minute and new cannula site access established and re-initiation of veno-venous (v-v) ecmo.Massive blood transfusion.

• Brand Name: BIO-MEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 4340 swinnea rd. ms ss-46; memphis TN 38118
• MDR Report Key: 6604249
• MDR Text Key: 76402430
• Report Number: 6604249
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2020
• Device Lot Number: 2016120609
• Other Device ID Number: 15 FR 5.0 MM X 18 CM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 49 YR