FDA Adverse Event
Death
Summary report: N
HEART LUNG MACHINE
MDR report key: 14315779
·
Received May 7, 2022
Report
- Report Number
- 8010762-2022-00153
- Event Type
- Death
- Date Received
- May 7, 2022
- Date of Event
- May 4, 2022
- Report Date
- May 12, 2022
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.
Additional Manufacturer Narrative · 0
THIS IS A FOLLOW UP REPORT TO COMPLAINT OT#(B)(4) THAT WAS REPORTED UNDER MFR REPORT# 8010762-2022-00153 ON (B)(6) 2022, WHICH IS A DUPLICATE ENTRY TO COMPLAINT OT# (B)(4), REPORTED UNDER MFR REPORT# 8010762-2022-00150 ON (B)(6) 2022.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DISPLAYED FLOW OF THE ROTAFLOW IS UNDER DELIVERING SETTING WHERE AT 5 LPM. THE FAILURE OCCURRED DURING PATIENT TREATMENT. COMPLAINT ID: (B)(4).
Description of Event or Problem · 0
COMPLAINT ID:(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204912 | HEART LUNG MACHINE | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | MAQUET CARDIOPULMONARY GMBH | ROTAFLOW ENGLISH/US US-PLUG ICU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |