MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS CUSTOM PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BB7V76R

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

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.The leurlock/phlange of a stopcock loosened and air was entrained into a pigtail line on the venous side of the circuit.

• Brand Name: CUSTOM PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis MN 55428
• MDR Report Key: 10061159
• MDR Text Key: 191157106
• Report Number: 10061159
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BB7V76R
• Device Catalogue Number: CUSTOM PACK
• Device Lot Number: 217707126
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 120 DA