N
Patient 1
THE EVENT DATE ENTERED IS MONTH AND YEAR VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9334255
- MDR report key
- 9334255
- Report number
- 9612164-2019-04774
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-08-01
- Date received
- 2019-11-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- PAULA BIXBY
- Address
- 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3/8 X 3/8 X 3/8 Y | TUBING, PUMP, CARDIOPULMONARY BYPASS | MEDTRONIC MEXICO | DWE | 6031 | 6031 | 216211872 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-18 | 0 | 1. R |
Event Narratives#
D
Patient 1
MEDTRONIC RECEIVED INFORMATION THAT ABOUT 20:00 HRS DURING THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE, THE CUSTOMER REPORTED LEAKING FROM AROUND THE Y-CONNECTOR THAT CONNECTED THE LV VENT TO THE VENOUS DRAINAGE LINE ON THE ECMO CIRCUIT. THE CUSTOMER WAS CONCERNED THAT THE LEAK WAS EITHER DUE TO A LOOSE CONNECTION OR THAT ONE OF THE LINES WAS FRACTURED. FOLLOWING NOTIFICATION TO THE PERFUSIONIST, MD AND SURGEON, THEY INTENDED TO FIX THE ISSUE USING A ZIP TIE AND BONE WAX. HOWEVER, AROUND 21:00 HRS, THE Y-CONNECTOR THE BROKE AND THE PATIENT BEGAN TO EXSANGUINATE. FLOWS WERE LOST AND CPR WAS INITIATED. THEY THEN CLAMPED THE ECMO CANNULA, MASS TRANSFUSION PROTOCOL WAS INITIATED, PATIENT WAS INTUBATED AND A LINE WAS PLACED. THEY WERE ABLE TO REPLACE THE Y-CONNECTOR AND RE-ESTABLISH FLOW.
N
Patient 1
VISUAL ANALYSIS: VISUAL INSPECTION SHOWS ONE OF THE 3/8 INCH TUBING CONNECTIONS HAS BROKEN OFF. DEVICE WAS CLEANED USING A 10% BLEACH SOLUTION. CONCLUSION; BASED ON THE INVESTIGATION RESULTS IT CAN BE CONCLUDED THAT THERE IS NOT ENOUGH EVIDENCE TO SAY THAT THE DAMAGE WAS CAUSE DURING THE MANUFACTURING PROCESS SINCE THE HANDLING OF THE CONNECTOR PERFORMED DURING THE INSPECTION AND PACKAGING DOES NOT REQUIRED TO APPLY FORCE THAT COULD DAMAGE THE PORTS OF THE CONNECTOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.