FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT 2 WAVE GERMAN
MDR report key: 1002586
·
Received February 8, 2008
Report
- Report Number
- 1219856-2008-00026
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 17, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K060309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED WITHOUT INCIDENT. THE IAB WAS CONNECTED TO THE PUMP; THE PUMP ALARMED DURING A PUMPING "LOW HELIUM TANK PRESSURE." THE RN STATED, THE HELIUM TANK PRESSURE DROPPED VERY FAST FOR THE 2000PSI HELIUM TANK. AS A RESULT, THE PUMP WAS EXCHANGED. THERE WERE NO REPORTED PT COMPLICATIONS. INFO RECEIVED FROM A THIRD PARTY SERVICE ORGANIZATION IS AS FOLLOWS: "A DEFECTIVE HELIUM REGULATOR WAS FOUND. A NEW HELIUM REGULATOR WAS BUILT IN."
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 (BRAND UNKNOWN) |