CARDIOSAVE HYBRID TYPE B PLUG
Report
- Report Number
- 2249723-2019-01130
- Event Type
- Malfunction
- Date Received
- July 19, 2019
- Report Date
- September 12, 2019
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPLACED THE HI PRESSURE HELIUM REGULATOR AND THE REGULATOR HOUSING BUSHING. THE FSE THEN PERFORMED TESTING AND THE UNIT PASSED ALL CALIBRATIONS, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.
UPDATED FIELDS: B4,D4(SERIAL NUMBER),G4,G7,H2,H4, H10, H11. CORRECTED : A1, A3. THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) IS NOT REQUIRED TO BE REVIEWED PER GETINGE STANDARD OPERATING PROCEDURE SINCE THE IABP WAS MANUFACTURED MORE THAN A YEAR BEFORE THE DATE OF EVENT.
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPLACED THE HI PRESSURE AND HELIUM REGULATOR. THE FSE THEN PERFORMED TESTING. UNIT PASSED ALL CALIBRATIONS, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.
IT WAS REPORTED BY THE CUSTOMER THAT WHILE PERFORMING A ROUTINE CHECK OF THE INTRA-AORTIC BALLOON PUMP (IABP) CARDIOSAVE, THE IABP HAD A HELIUM LEAK. THE CUSTOMER STATED A PREVIOUS COMPLAINT WAS MADE AND THE GETINGE FIELD SERVICE ENGINEER (FSE) CAME TO EVALUATE THE UNIT BUT COULD NOT REPRODUCE THE ISSUE AT THE TIME. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.
IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON PUMP (IABP) CARDIOSAVE IS LEAKING HELIUM. THE CUSTOMER STATED A PREVIOUS COMPLAINT WAS MADE AND THE GETINGE FIELD SERVICE ENGINEER (FSE) CAME TO EVALUATE THE UNIT BUT COULD NOT REPRODUCE THE ISSUE AT THE TIME. IT IS UNKNOWN THE CIRCUMSTANCE OF THIS EVENT ; IT IS ALSO UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. HOWEVER, NO ADVERSE EVENT WAS REPORTED.
IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON PUMP (IABP) CARDIOSAVE IS LEAKING HELIUM. THE CUSTOMER STATED A PREVIOUS COMPLAINT WAS MADE AND THE GETINGE FIELD SERVICE ENGINEER (FSE) CAME TO EVALUATE THE UNIT BUT COULD NOT REPRODUCE THE ISSUE AT THE TIME. IT IS UNKNOWN THE CIRCUMSTANCE OF THIS EVENT; IT IS ALSO UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. HOWEVER, NO ADVERSE EVENT WAS REPORTED.
THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS UNABLE TO BE REVIEWED AS WE WERE NOT ABLE TO OBTAIN THE SERIAL NUMBER FOR THE IABP ASSOCIATED WITH THIS COMPLAINT. AT THIS TIME, THE CUSTOMER HAS NOT REQUESTED GETINGE TO EVALUATE THE IABP. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE CUSTOMER WITH REGARD TO THE REPAIR AND STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THIS INFORMATION IS PROVIDED TO US.
IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON PUMP (IABP) CARDIOSAVE IS LEAKING HELIUM. THE CUSTOMER STATED A PREVIOUS COMPLAINT WAS MADE AND THE GETINGE FIELD SERVICE ENGINEER (FSE) CAME TO EVALUATE THE UNIT BUT COULD NOT REPRODUCE THE ISSUE AT THE TIME. IT IS UNKNOWN THE CIRCUMSTANCE OF THIS EVENT ; IT IS ALSO UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. HOWEVER, NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602670 | CARDIOSAVE HYBRID TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |