FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT2 WAVE ITALIAN
MDR report key: 3983384
·
Received July 7, 2014
Report
- Report Number
- 1219856-2014-00123
- Event Type
- Malfunction
- Date Received
- July 7, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE / PARTS WILL NOT BE RETURNED DUE TO BLOOD CONTAMINATION.
Description of Event or Problem · 1
IT WAS REPORTED VIA AN EXPEDITED QUALITY REVIEW (EQR) REPORT: SYMPTOM - THE PUMP WAS FIRST CHOICE, BUT SUDDENLY STARTED GIVING PROBLEMS. THEY SWITCHED FROM AN AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP TO AN ACAT 1. ACTIONS: BLOOD BACKED UP INTO THE PNEUMATIC SYSTEM. THE ENTIRE PUMP ASSEMBLY HAS BEEN REPLACED. THE PATIENT WAS STILL UNDER THERAPY WITH THE ACAT 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395090 | AUTOCAT2 WAVE ITALIAN | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |