FDA Adverse Event
Malfunction
Summary report: N
ACAT 1 IAB PUMP ASSEMBLY
MDR report key: 1051440
·
Received May 21, 2008
Report
- Report Number
- 1219856-2008-00240
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- February 26, 2008
- Report Date
- May 21, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K965209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL BIOMED DEPARTMENT EVALUATED THE CONSOLE. THEY COULD NOT REPRODUCE THE SOFTWARE FAILURE ERROR. THEY RAN THE PUMP IN BIOMED FOR FOUR HOURS. MANUFACTURER PERFORMED PREVENTATIVE MAINTENANCE. WORLDWIDE SUPPORT FUNCTIONAL CHECK LIST AND ELECTRICAL SAFETY TEST - PASSED. THE SYMPTOM OF ERROR CODE SOFTWARE FAILURE COULD NOT BE DUPLICATED. (THE PUMP IS DESIGNED TO GIVE SPECIFIC SYSTEM ERROR ALARMS. "SOFTWARE FAILURE" IS NOT A PROGRAMMED PUMP ERROR CODE).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HOSPITAL BIOMED DEPARTMENT CONTACTED ARROW FIELD SERVICE ADVISING THAT THE ACAT 1+ PUMP HAD TWICE STOPPED PUMPING WHILE ON PT. THE PUMP WAS GIVING AN ERROR CODE OF SOFTWARE FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACAT 1 IAB PUMP ASSEMBLY | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |