FDA Adverse Event
Malfunction
Summary report: N
BE-PLS 2050 PERMENANT LIFE SUPPORT
MDR report key: 3727135
·
Received February 27, 2014
Report
- Report Number
- 8010762-2014-00099
- Event Type
- Malfunction
- Date Received
- February 27, 2014
- Date of Event
- February 7, 2014
- Report Date
- February 17, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DTZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE IS NOT DISTRIBUTED IN USA BUT SIMILAR DEVICE IS DISTRIBUTED UNDER K112360. THE MFR HAS NOT REC'D THE DEVICE FOR INVESTIGATION. A REQUEST TO OBTAIN THE DEVICE WAS ISSUED. ONCE THE DEVICE BECAME AVAILABLE, THE INVESTIGATION WILL BEGIN TO DETERMINE THE ROOT-CAUSE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, A BLOOD LEAKAGE OCCURRED FROM THE BOTTOM OF THE PLS OXYGENATOR FROM THE GAS OUTLET PLACED ON THE BOTTOM OF THE DEVICE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122233 | BE-PLS 2050 PERMENANT LIFE SUPPORT | PERMENANT LIFE SUPPORT OXYGENATOR | DTZ | MAQUET CARDIOPULMONARY AG | 70102.7818 | 70086001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |