MAUDE Adverse Event Report: SPECTRUM MEDICAL/QURA S.R.L. SPECTRUM MEDICAL DUAL LUMEN CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number DL27F-V0

Device Problems Crack (1135); Air/Gas in Device (4062)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2023

Event Type  Injury  

Event Description

The spectrum cannula of a right ventricular assist device (rvad) cracked at the insertion site while in use on the patient.This led to air entrapment.The rvad detected the air and shut off appropriately.The rvad and cannula were removed from the patient.

• Brand Name: SPECTRUM MEDICAL DUAL LUMEN CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL/QURA S.R.L.
• MDR Report Key: 16947574
• MDR Text Key: 315490048
• Report Number: MW5117591
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2023

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
• Device Operator: Health Professional
• Device Model Number: DL27F-V0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic
• Patient Race: White