CARDIOSAVE HYBRID, 3.1 EDITION
Report
- Report Number
- 2249723-2024-02142
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- May 15, 2024
- Report Date
- February 10, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567113432
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UDI RELATED DATA QUALITY UPDATES ONLY. PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.
CORRECTED DATA: B5, E1 (CITY AND SITE NAME). UPDATED DATA: B4, E1(ADDRESS), G3, G6, H2, H10, H11.
UPDATED FIELDS: B4,D1,D4 (VERSION OR MODEL #, CATALOG#), D9, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSION), H10. ADDITIONAL CONTACT DETAILS: EVENT SITE POSTAL CODE - 2240001. IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WITH BALLOON RUPTURE. A GETINGE FIELD SERVICE ENGINEER EVALUATED, NO BLOOD WAS FOUND INSIDE. THE OPERATION CHECK HAS BEEN CARRIED OUT. THE EQUIPMENT IS IN GOOD CONDITION. OCCURS DURING CLINICAL USE. PATIENT INVOLVED.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS POLLUTED BY BLOOD. THERE WAS NO IMPACTS ON PATIENT.
N/A.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE BALLOON RUPTURED AND THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS POLLUTED BY BLOOD. THERE WAS NO IMPACTS ON PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 501076 | CARDIOSAVE HYBRID, 3.1 EDITION | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-65 | 10607567113432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |