FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE
MDR report key: 4093219
·
Received August 21, 2014
Report
- Report Number
- 2249723-2014-00890
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- March 1, 2012
- Report Date
- March 1, 2012
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE COMPANY REPRESENTATIVE VERIFIED SOME LIQUID CONTAMINATION ON FRONT END BOARD. THE COMPANY REPRESENTATIVE REPLACED THE FRONT END BOARD (PART NUMBER: 0670-00-0769). IN AN UNRELATED EVENT, THE COMPANY REPRESENTATIVE INSTALLED THE SOFTWARE. THE COMPANY REPRESENTATIVE RAN PERFORMANCE TESTS. THE IABP PASSED THE PERFORMANCE TESTS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, A "SALINE BAG RUPTURED ON A CARDIOSAVE", THE IABP GENERATED AN ALARM "INTERNAL COMMUNICATION FAILURE". THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504553 | CARDIOSAVE | INTRA-AORTIC BALLOON PUMP | DSP | DATASCOPE CORP. | CARDIOSAVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |