CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0002442
- Event Type
- Malfunction
- Date Received
- June 3, 2025
- Date of Event
- May 19, 2025
- Report Date
- March 7, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. CORRECTED FIELD: D5, E1 (INITIAL REPORTER, EVENT SITE ADDRESS), E2, E3, E4, G2. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. UPON INSPECTION, THE UNIT SHOWED SEVERAL SIGNS OF CUSTOMER ABUSE. THE REAR COVER SHOWED SEVERAL DENTS AND A BROKEN HANDLE. AN AUDIBLE HELIUM LEAK WAS CONFIRMED WHEN THE UNIT POWERED ON. THE FILL MANIFOLD SHOWED DAMAGE AND WAS BENT. THE VACUUM AND PRESSURE TUBE WERE BOTH PINCHED. THE HELIUM RESERVOIR WAS LOOSENED. THE FSE REPLACED THE FOLLOWING PARTS: PRESSURE TUBE ASSEMBLY (0004-00-0093), HELIUM RESERVOIR ASSEMBLY (0997-00-0565), VACUUM TUBE ASSEMBLY (0004-00-0092), CONSOLE COVER (0441-00-0194), REAR HANDLE (0367-00-0114), BACK COVER WASHER (0221-00-0160 X2), HELIUM TUBING ASSEMBLY .020 ID (0004-00-0103-01), HELIUM TUBING ASSEMBLY .005 ID (0004-00-0103-03). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF CUSTOMER REPORTED HELIUM LEAK. UPON INSPECTION, UNIT HAD DAMAGE TO REAR COVER AND THE HELIUM RESERVOIR WAS LOOSE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION, HOWEVER CHECK VALVE (CV1) WAS LOOSE. THE FAT DEPT. TIGHTENED UP THE CHECK VALVE. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0997-00-0565 ASSY, HELIUM REGULATOR SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE HELIUM RESERVOIR TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. PROCEEDED TO PERFORM TO TEST THE SOLENOIDS. K3 SOLENOID WAS NOT WORKING. THE HELIUM RESERVOIR FAILED TESTING. PROBABLE CAUSE FOR THE HELIUM LEAK WAS WAS A DEFECTIVE K3, MORE LIKELY DAMAGED, WHEN THE BACK COVER OF THE CONSOLE WAS DAMAGED, ALTHOUGH THE RESERVOIR APPEARED TO BE IN GOOD CONDITION. RETAINING THE HELIUM RESERVOIR IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU. BASED ON THE EVALUATION RESULTS PROVIDED BY THE FSE, THE REMAINING PARTS THAT WERE DAMAGED DUE TO CUSTOMER ABUSE ARE NOT AVAILABLE FOR RETURN. THE ISSUE WAS RESOLVED BY REPLACING THE MALFUNCTIONING PARTS. THIS IS CONSIDERED A USER ERROR.
UPDATED FIELDS: B4, D9, E1 INITIAL REPORTER, EVENT SITE EMAIL, G1, G3, G6, H2, H3, H6, H11 CORRECTED FIELDS: E2. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD AN HELIUM LEAK PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
N/A.
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205520 | 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 | NA | Unknown | N/A. |