FDA Adverse Event
Malfunction
Summary report: N
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
MDR report key: 17527033
·
Received August 12, 2023
Report
- Report Number
- MW5133969
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- February 20, 2013
- Manufacturer
- CENTURY HLM, LLC
- Product Code
- DTQ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT EACH MORNING THE BATTERY STATUS (ACCRATECH BATTERIES ) OF THE CENTURY PUMP IS TESTED BY UNPLUGGING IT FROM THE WALL, LISTENING FOR THE AUDIBLE TONE TO STATE THE UNIT IS ON BATTERY POWER, THEN PLUG IT BACK IN. THE AUDIBLE TONE ON MOST OF THE PUMPS WILL STOP WHEN PLUGGED BACK IN. HOWEVER, WITH SOME OF THE PUMPS, THE TONE WILL NOT STOP WHEN PLUGGED BACK IN. THE BATTERY IS BEING REPLACED ON THE PUMP IN ROOM 1 (B)(4). RECENTLY 2 OTHER PUMPS HAVE EXPERIENCED THE SAME ISSUE (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2218445 | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | CENTURY HLM, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |