FDA Adverse Event
Death
Summary report: N
ECMOTHERM II HEAT EXCHANGER
MDR report key: 288686
·
Received August 7, 2000
Report
- Report Number
- 2184009-2000-00064
- Event Type
- Death
- Date Received
- August 7, 2000
- Date of Event
- July 7, 2000
- Report Date
- August 7, 2000
- Manufacturer
- MEDTRONIC PERFUSION SYSTEMS
- Product Code
- DTR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS EVIDENCE OF HEMOLYSIS WITHIN THE CIRCUIT. REQUESTS HEAT EXCHANGER TO BE TESTED. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECMOTHERM II HEAT EXCHANGER | HEAT EXCHANGER | DTR | MEDTRONIC PERFUSION SYSTEMS | ECMO II | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 DAY | Death |