FDA Adverse Event
Injury
Summary report: N
70104.8012# CARDIOHELP-I
MDR report key: 5492914
·
Received March 10, 2016
Report
- Report Number
- 8010762-2016-00164
- Event Type
- Injury
- Date Received
- March 10, 2016
- Date of Event
- February 13, 2016
- Report Date
- May 30, 2017
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTQ
- PMA / PMN Number
- K102726
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL BE INVESTIGATED BY A MAQUET SERVICE TECHNICIAN. A SUPPLEMENTAL MEDWATCH WILL BEE SUBMITTED AS SOON AS IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4), MFR. REPORT # 8010762-2016-00162. THE INFORMATION RECEIVED WAS FROM A DIFFERENT SOURCE, WITH DIFFERENT DESCRIPTION BUT IT HAS BEEN CONFIRMED TO BE FROM THE SAME INCIDENT/SAME CUSTOMER/SAME DEVICE. PLEASE REFER TO FOLLOW UP REPORT #1 OF (B)(4), MFR. REPORT # 8010762-2016-00162 FOR INFORMATION UPDATE ON THE FINAL RESOLUTION TO THIS ISSUE.
Description of Event or Problem · 1
(B)(4). IT WAS REPORTED THAT THE PATIENT CODED WHEN ON THE CARDIOHELP. THE DEVICE WAS REPLACED DURING PATIENT TREATMENT. IT WAS CONFIRMED THAT THE PATIENT DID NOT DIE. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149348 | 70104.8012# CARDIOHELP-I | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY AG | 701048012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |