CADD
Report
- Report Number
- 3012307300-2020-02481
- Event Type
- Malfunction
- Date Received
- April 2, 2020
- Date of Event
- March 3, 2020
- Report Date
- December 11, 2020
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 10610586027536
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP. THE SAMPLE WAS TESTED FOR LEAKING USING HYDROSTAT. THIS WAS CONFIRMED AND OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. ROOT CAUSE IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA-000542 WAS OPEN ON 30-APR-2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER. ACTION TAKEN: BY THE DATE THAT IS INVESTIGATION REPORT IS DOCUMENTED, THIS CAPA-000542 WAS CLOSED ON 23-JUL-2020 AND THE CORRECTIVE ACTION INCLUDED ON THIS INVESTIGATION WAS REMOVED FROM THE SCOPE AND INCLUDED IN PROJECT (B)(4), THAT IT WILL ADDRESS THIS REPORTED TO INCLUDE ADDITIONAL IFU VERBIAGE TO INFORM CUSTOMER OF THE PRODUCTS THAT SHOULD NOT BE USED WHEN TRANSFERRING FLUID TO THE MEDICATION CASSETTES. THE PROJECT INFORMATION REFERENCE CAN BE FOUND IN (B)(4).
OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP . THE SAMPLE WAS TESTED FOR LEAKING USING HYDROSTAT. THIS WAS CONFIRMED AND OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. ROOT CAUSE IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA-000542 WAS OPEN ON (B)(6) 2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER. ACTION TAKEN BY THE DATE THAT IS INVESTIGATION REPORT IS DOCUMENTED, THIS CAPA-000542 WAS CLOSED ON (B)(6) 2020 AND THE CORRECTIVE ACTION INCLUDED ON THIS INVESTIGATION WAS REMOVED FROM THE SCOPE AND INCLUDED IN PROJECT 100034, THAT IT WILL ADDRESS THIS REPORTED TO INCLUDE ADDITIONAL IFU VERBIAGE TO INFORM CUSTOMER OF THE PRODUCTS THAT SHOULD NOT BE USED WHEN TRANSFERRING FLUID TO THE MEDICATION CASSETTES. THE PROJECT INFORMATION REFERENCE CAN BE FOUND IN (B)(4).
OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP . THE SAMPLE WAS TESTED FOR LEAKING USING HYDROSTAT. THIS WAS CONFIRMED AND OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. ROOT CAUSE IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA-000542 WAS OPEN ON (B)(6) 2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER. ACTION TAKEN BY THE DATE THAT IS INVESTIGATION REPORT IS DOCUMENTED, THIS CAPA-000542 WAS CLOSED ON (B)(6) 2020 AND THE CORRECTIVE ACTION INCLUDED ON THIS INVESTIGATION WAS REMOVED FROM THE SCOPE AND INCLUDED IN PROJECT 100034, THAT IT WILL ADDRESS THIS REPORTED TO INCLUDE ADDITIONAL IFU VERBIAGE TO INFORM CUSTOMER OF THE PRODUCTS THAT SHOULD NOT BE USED WHEN TRANSFERRING FLUID TO THE MEDICATION CASSETTES. THE PROJECT INFORMATION REFERENCE CAN BE FOUND IN (B)(4).
INVESTIGATION COMPLETED.
INVESTIGATION COMPLETED AND SUMMARY IN H 10.
INVESTIGATION COMPLETED AND SUMMARY IN H 10.
REPORT SOURCE: SINGAPORE.
INFORMATION WAS RECEIVED THAT A NURSE DISCOVERED A POTENTIAL LEAK ON SMITHS MEDICAL CADD ADMINISTRATION SET AT THE IN-LINE FILTER SITE OF THE 0.22 MICRON CADD ADMINISTRATION SET THE GAUZE USED TO WRAP THE SET IS SOAKED WITH CHEMOTHERAPY DRUGS. THE PUMP SETTING WAS 500ML/24HRS. DRUGS USED ARE ETOPOSIDE/DOXORUBICIN/ZINCIRSTINE. THE REPORTED EVENT OCCURRED WHILE IN USE WITH A PATIENT DURING REMOVAL/END OF THERAPY. THERE WAS NO REPORTED PATIENT INJURY. "INFUSION WAS FOR CHEMOTHERAPY THAT IS TREATING A LIFE THREATENING ILLNESS, BUT NOT STRICTLY LIFE SUSTAINING AS IF IT WAS A VASOPRESSOR. PATIENT RETURNED AFTER THE COMPLETION OF THE PUMP. WE ASSUME ANY LEAKS FROM THIS SITE WAS OF NEGLIGIBLE VOLUME AND NOT IMPACTFUL OF THE PATIENT'S TREATMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378360 | CADD | CADD ADMINISTRATION SETS | FPA | ST PAUL | 21-7394-24 | 3860307 | 10610586027536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |