CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-03754
- Event Type
- Malfunction
- Date Received
- September 13, 2024
- Date of Event
- August 24, 2024
- Report Date
- May 15, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED DATA: B4, B5, E1 (EMAIL), G2, G3, G6, H2, H10, H11 CORRECTED DATA: E4.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS: E4. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND NO SPECIFIC FAULTS PRESENT FOR OVER TEMP SYSTEM, RAN UNIT FOR 12 HOURS ON SIMULATOR AND OVER TEMP OCCURRED. THE FSE REPLACED THE PRESSURE VACUUM DRIVE REGULATORS AND FILTER. SYSTEM LEFT IN BIOMED ON SIMULATOR TO RUN FOR EXTENDED PERIOD TO ATTEMPT TO RECREATE OVER TEMP FAILURE. SYSTEM FAILED FOR OVER TEMP AGAIN, FSE REPLACED POWER MANAGEMENT BOARD AND SYSTEM WAS LEFT IN BIOMED ON SIMULATOR TO RUN FOR EXTENDED PERIOD TO ATTEMPT TO RECREATE OVER TEMP. SYSTEM FAILED FOR OVER TEMP A 3RD TIME, SO FSE REPLACED TEMPERATURE SENSOR, THREADED PROBE. SYSTEM CURRENTLY RUNNING EXTENDED RUNTIME TEST ON SIMULATOR TO ATTEMPT TO RECREATE OVER TEMP ERROR. SYSTEM OPERATED ON SIMULATOR FOR 24 HOURS AT 130 BPM WITHOUT OVER TEMP FAILURE OR ALARM. SYSTEM RELEASED TO CUSTOMER.
FDA MEDWATCH (B)(4) RECEIVED ON 05-SEPT-2024 STATED THE FOLLOWING: AT 1004 HOURS, THE INTRA-AORTIC BALLOON PUMP (IABP) DEVICE IN USE TRIGGERED A HIGH-PRIORITY ALARM INDICATING AN ELECTRICAL HARDWARE FAILURE. THIS ALARM NECESSITATED IMMEDIATE INTERVENTION FROM THE MEDICAL TEAM. FOLLOWING THE ALARM, THE DEVICE EXPERIENCED A SHUTDOWN AND THE PUMP STOPPED FUNCTIONING DUE TO THE INTERNAL DEVICE TEMPERATURE EXCEEDING ITS THRESHOLD. IMMEDIATE ACTIONS TAKEN: ALARM RESPONSE: THE BEDSIDE RN (REGISTERED NURSE), PROMPTLY ACKNOWLEDGED THE ALARM AND ASSESSED THE SITUATION. DEVICE SWAP: RECOGNIZING THE URGENCY, RN RETRIEVED AN ADDITIONAL IABP DEVICE FROM THE SUPPLY ROOM. ASSISTANCE: THE CARDIOLOGY MD TEAM RESPONDED TO THE BEDSIDE TO ASSIST WITH THE DEVICE REPLACEMENT PROCESS. OUTCOME: THE PATIENT CONTINUED TO RECEIVE NECESSARY CARDIAC SUPPORT WITH THE NEW IABP DEVICE, ENSURING MINIMAL DISRUPTION IN CARE. THE REPLACEMENT WAS CARRIED OUT SUCCESSFULLY WITH NO IMMEDIATE ADVERSE EFFECTS REPORTED. FOLLOW-UP ACTIONS: DEVICE INSPECTION: THE MALFUNCTIONING IABP DEVICE WILL BE GIVEN TO MANAGEMENT FOR FURTHER INSPECTION. REVIEW: A REVIEW OF THE INCIDENT WILL BE CONDUCTED TO DETERMINE THE CAUSE OF THE HARDWARE FAILURE AND TO ENSURE COMPLIANCE WITH SAFETY STANDARDS. DOCUMENTATION: THIS REPORT WILL BE FILED WITH THE HOSPITAL¿S RISK MANAGEMENT TEAM.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN OVERHEAT ERROR, CUSTOMER CALLED AND STATED PUMP HAD ALARMED SYSTEM OVER TEMPERATURE TWICE. THE NURSING STAFF HAD POWERED OFF AND THEN POWERED ON THE PUMP BOTH TIMES TO RESUME PUMPING. THEY ATTEMPTED TO CHANGE TO A DIFFERENT PUMP, BUT THE SECOND PUMP HAD AUTOFILL FAILURE THREE TIMES ON STARTUP. CUSTOMER WAS INFORMED TO PUT THE SECOND PUMP IN RESCUE CONFIGURATION THEN RETURN IT TO HYBRID CONFIGURATION. THEY THEN PLACED THE PATIENT ON THE SECOND PUMP WITHOUT ISSUE. THERE WAS NO PATIENT HARM REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1637300 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | UNKNOWN. |