FDA Adverse Event
Injury
Summary report: N
BASIC 036 MEDELA SUCTION PUMP
MDR report key: 507298
·
Received January 16, 2004
Report
- Report Number
- 1419937-2003-00002
- Event Type
- Injury
- Date Received
- January 16, 2004
- Date of Event
- November 17, 2003
- Report Date
- January 15, 2004
- Manufacturer
- MEDELA AG MEDICAL TECHNOLOGY
- Product Code
- JCX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
WHEN MEDTRONIC STARFISH TISSUE STABILIZER, SUCTION DEVICE, WAS REMOVED FROM THE HEART AFTER CAS, A QUARTER SIZE TEAR WAS DISCOVERED NEAR THE SITE WHERE THE STABILIZER HAD BEEN ATTACHED. PT WAS PUT ON BYPASS AND THE TEAR WAS REPAIRED. LATER THAT DAY PT WAS RETURNED TO O.R. FOR POST-OP DUE TO CONTINUED BLEEDING AND TAMPONADE. PT THEN STABILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC 036 MEDELA SUCTION PUMP | POWERED SUCTION PUMP | JCX | MEDELA AG MEDICAL TECHNOLOGY | 036-1251 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | STARFISH 2 HEART POSITIONER, MEDTRONIC CARDIAC| SURGERY TECHNOLOGIES. |