MAUDE Adverse Event Report: MEDTRONIC, INC. CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BB7V76R

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

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

Event Date 01/31/2020

Event Type  malfunction  

Event Description

Connection loose and dislodged.Air entered circuit.Cpr done for 7 minutes while air removed.Peds small tubing pack - on the venous side of the circuit, second stopcock/pigtail set up connected to the cdi.The phlange/leur lock on the stopcock connected to this pigtail loosened and air was entering into the circuit.

Event Description

Connection loose and dislodged.Air entered circuit.Cpr done for 7 minutes while air removed.Peds small tubing pack - on the venous side of the circuit, second stopcock/pigtail set up connected to the cdi.The phlange/leur lock on the stopcock connected to this pigtail loosened and air was entering into the circuit.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 9847306
• MDR Text Key: 183909489
• Report Number: 9847306
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BB7V76R
• Device Catalogue Number: CUSTOM PACK
• Device Lot Number: 217707126
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2020
• Patient Sequence Number: 1
• Patient Age: 30 DA