CARDIOSAVE HYBRID W/ E/F PLUG
Report
- Report Number
- 2249723-2023-04621
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- October 17, 2023
- Report Date
- June 26, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
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 (D1, D2, D3, D4, G4, H4, H5).
A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND DETERMINED THAT HELIUM REGULATOR IS FAULTY. FSE RESOLVED THE ISSUE BY REPLACING THE D103-00-0637 REGULATOR, HI PRESSURE, HELIUM. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0103-00-0637 HELIUM REGULATOR SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF THE HELIUM BOTTLE COULD NOT BE INSERTED. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED A KNOWN GOOD HELIUM TANK INTO PART NUMBER 0103-00-0637 HELIUM REGULATOR SERIAL NUMBER (B)(6) AND OBSERVED THAT THE HELIUM TANK COULD BE INSERTED INTO THE HELIUM REGULATOR WITH NO PROBLEM FOUND PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639-REV. R. THE FAT DEPT. COULD NOT REPLICATE THE FAILURE. THE HELIUM REGULATOR PASSED TESTING. RETAINING THE HELIUM REGULATOR IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(6) REV. AR.
UPDATED FIELDS: B4, D8, D9 (RETURN TO MANUFACTURE DATE), E1 (EVENT SITE EMAIL AND INITIAL REPORTER), G1, G3, G6, H2, H11. CORRECTED FIELDS: B5, G2, H6 (INVESTIGATION FINDINGS). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND DETERMINED THAT HELIUM REGULATOR IS FAULTY. FSE RESOLVED THE ISSUE BY REPLACING THE D103-00-0637 REGULATOR, HI PRESSURE, HELIUM. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 21 OCT 2024. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0103-00-0637 HELIUM REGULATOR SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF THE HELIUM BOTTLE COULD NOT BE INSERTED. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED A KNOWN GOOD HELIUM TANK INTO PART NUMBER 0103-00-0637 HELIUM REGULATOR SERIAL NUMBER 021692 AND OBSERVED THAT THE HELIUM TANK COULD BE INSERTED INTO THE HELIUM REGULATOR WITH NO PROBLEM FOUND PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639-REV. R. THE FAT DEPT. COULD NOT REPLICATE THE FAILURE. THE HELIUM REGULATOR PASSED TESTING. RETAINING THE HELIUM REGULATOR IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AR. THE MOST PROBABLE ROOT CAUSE IS WITH THE YOKE OF THE HELIUM TANK NOT LINING UP WITH THE HOLES ON THE HELIUM REGULATOR. BR 21 OCT 2024. WHEN THE HELIUM TANK IS INSTALLED IN THE CARDIOSAVE IABP IT CONNECTS TO THE HIGH PRESSURE HELIUM REGULATOR WHICH IS LOCATED IN THE HOSPITAL CART. THE REGULATOR HAS TWO INDEXED PINS WHICH ALIGN WITH TWO HOLES ON THE HELIUM TANK VALVE. BOTH THE PINS ON THE REGULATOR AND THE HOLES IN THE TANK VALVE HAVE AN ALLOWABLE TOLERANCE FOR THEIR PLACEMENT. IF BOTH PARTS ARE WITHIN THEIR ALLOWABLE TOLERANCE, THEY WILL BE ABLE TO CONNECT. HOWEVER, A NUMBER OF 0202-00-0104 (ALSO REFERRED TO AS D202-00-0104) DISPOSABLE HELIUM TANKS HAVE BEEN IDENTIFIED AS HAVING THE LOCATION OF THEIR INDEX PIN HOLES OUT OF TOLERANCE. THIS OUT OF TOLERANCE CONDITION PREVENTS THE HELIUM TANK FROM CONNECTING TO SOME REGULATORS. ADDITIONALLY, THERE WERE A FEW REGULATORS THAT HAD PINS OUT OF TOLERANCE THAT WERE STILL ABLE TO BE SECURED INTO THE HELIUM TANK. THE ISSUES WITH THE HELIUM CYLINDER TANK ARE BEING INVESTIGATED UNDER 23-SCAR-CAHW-021. BR 21 OCT 2024.
IT WAS REPORTED THAT DURING INSTALLATION AT THE REPAIR CENTER THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM BOTTLE CANNOT BE USED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
N/A.
IT WAS REPORTED THAT DURING INSTALLATION AT THE REPAIR CENTER, AN ERROR WAS IDENTIFIED DURING THE COMMISSIONING. THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND TO HAVE AN ISSUE WHERE THE HELIUM BOTTLE COULD NOT BE INSERTED. NO PATIENT INVOLVEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2128528 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |