CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2024-00761
- Event Type
- Malfunction
- Date Received
- February 21, 2024
- Date of Event
- February 13, 2024
- Report Date
- November 22, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. E1 INITIAL REPORTER WAS SHORTENED DUE TO CHARACTER LIMITATIONS. THE COMPLETE NAME IS (B)(6).
A GETINGE FIELD SERVICE ENGINEER (FSE) SAYS UNIT SURFACED A FIBER OPTIC SENSOR FAILURE PROMPT WHILE ON PATIENT. UNIT NEVER STOPPED WORKING OTHERWISE, AND FULLY FUNCTIONAL. UNIT JUST FAILED TO DISPLAY BLOOD PRESSURE WAVE FORM VIA THE FIBER OPTIC. FSE WAS UNABLE TO REPLICATE USER COMPLAINT. SUCCESSFULLY COMPLETED A SIMULATED TREATMENT ON UNIT WITH TESTING CATHETER AND TRAINER WITHOUT ISSUE UPON INITIALLY TESTING UNIT. SUCCESSFULLY COMPLETED A FUNCTION CHECK ON THE FIBER OPTIC WHILE RUNNING WITH TRAINER AND CATHETER SUCCESSFULLY OBTAINING BLOOD PRESSURE WAVEFORM AND VALUES. UNIT DID RECOGNIZED FIBER OPTIC WHEN CONNECTED, AND FIBER OPTIC CONNECTOR INTACT AND IN GOOD CONDITION. IDENTIFIED A FIBER OPTIC FAILURE IN THE LOGS. REPLACED FIBER OPTIC MODULE AND CABLE AS A PRECAUTION. POST REPLACEMENT, SUCCESSFULLY COMPLETED FULL SYSTEM CHECK OUT WITHOUT EXCEPTION. UNIT CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS AND RETURNED TO CUSTOMER. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0997-00-1169 SN (B)(6)AND PN 0012-00-1808. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED PN 0997-00-1169 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO ISSUE CONFIRMED. THE FAT INSTALLED PN 0012-00-1808 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO ISSUE CONFIRMED SENT THE BOARDS FROM PN 0997-00-1169 TO THE RESPECTIVE SUPPLIER PER PROCEDURE. RETAINING PN 0012-00-1808 IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE FOLLOWING WAS INPUT BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAT RECEIVED THE FAILURE ANALYSIS FROM THE SUPPLIER FOR PN 0992-00-1017 SN (B)(6). SUPPLIER STATED THE ROOT CAUSE IS THE OPTICAL BLOC BEING BAD BUT DID NOT STATE HOW THIS WAS POSSIBLE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAT DEPT. RECEIVED PART NUMBER 0670-00-1160 REV A, FIBER OPTIC INTERFACE MODULE BOARD SERIAL NUMBER (B)(6) FROM THE SUPPLIER. SUPPLIER INVESTIGATION: PERFORMED VISUAL CHECK AND NO ABNORMALITY FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULT AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. RETAINING THIS BOARD IN THE FAT DEPT. PER PROCEDURE.
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FIBER OPTIC SENSOR MODULE FAILURE. NO PATIENT HARM OR INJURY REPORTED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1575905 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |