FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT 2 WAVE GERMAN
MDR report key: 2033873
·
Received February 11, 2011
Report
- Report Number
- 1219856-2011-00056
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 10, 2011
- Manufacturer
- ARROW INTL INC
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE OP, AN INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON PUMP (IABP) WAS ON THE PT AND THE PUMP ALARMED HELIUM LOSS ALERT, REOCCURRING REGULARLY. THE STAFF CHANGED THE PUMP WITHOUT ANY PROBLEMS. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. A DELAY IN TREATMENT WAS NOT NOTED. THE PT OUTCOME IS OKAY. ADDITIONAL INFO RECEIVED ON (B)(6) 2011, STATED THAT THE IABP IS WITH A THIRD PARTY ORGANIZATION FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOCAT 2 WAVE GERMAN | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL INC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | INTRA-AORTIC BALLOON |