ALARIS ETCO2
Report
- Report Number
- 2016493-2021-10478
- Event Type
- Malfunction
- Date Received
- January 15, 2021
- Report Date
- January 8, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- CCK
- UDI-DI
- 10885403830013
- PMA / PMN Number
- K031741
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
TECHNICAL SUPPORT PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE THE CUSTOMER REPORTED ISSUE OF: 8300 ERROR CODE 570.6500. TECHNICAL SUPPORT - IF YOU EXPERIENCE A CHANNEL ERROR CODE 570.6200 OR 570.6500 ON THE ETCO2 MODULE, REMOVE THE DEVICE FROM SERVICE AND SEND IT TO YOUR BIOMEDICAL ENGINEER(S). ACTIONS FOR BIOMEDICAL ENGINEERING: CONTACT THE BD RECALL SUPPORT CENTER AT 1-888-562-6018 TO SCHEDULE REMEDIATION OF YOUR ETCO2 MODULES AT NO CHARGE. PLEASE PROMPTLY COMPLETE AND RETURN THE CUSTOMER RESPONSE FORM TO ACKNOWLEDGE RECEIPT OF THIS NOTIFICATION AND THE RECALL INSTRUCTIONS PROVIDED IN THIS LETTER. ACTIONS FOR BD ALARIS¿ SYSTEM RENTAL PROVIDERS: PROVIDE A COPY OF THIS LETTER TO YOUR CUSTOMERS WHO ARE CURRENTLY RENTING BD ALARIS¿ SYSTEM DEVICES. ACTIONS BY BD: A BD REPRESENTATIVE WILL CONTACT ALL AFFECTED FACILITIES TO INITIATE THE REPLACEMENT OF THE ORIDION SUBASSEMBLY FOR THE AFFECTED ETCO2 MODULES. THIS REMEDIATION WILL BE PERFORMED AT NO CHARGE. THE U.S. FOOD AND DRUG ADMINISTRATION HAS BEEN NOTIFIED OF THIS ACTION. ANY ADVERSE REACTIONS EXPERIENCED WITH THE USE OF THIS PRODUCT, AND/OR QUALITY PROBLEMS SHOULD ALSO BE REPORTED TO THE FDA¿S MEDWATCH PROGRAM BY: WEB: MEDWATCH WEBSITE AT WWW.FDA.GOV/MEDWATCH PHONE: 1-800-FDA-1088 FAX: 1-800-FDA-0178, OR BY MAIL: MEDWATCH, HF-2, FDA, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787 CONTACT INFORMATION: IF YOU HAVE ANY QUESTIONS REGARDING THE PRODUCTS, PLEASE CONTACT: CONTACT CONTACT INFORMATION AREAS OF SUPPORT BD CUSTOMER ADVOCACY PHONE: 888-812-3266 PHONE HOURS: 7:00AM TO 5:00PM PT MONDAY ¿ FRIDAY EMAIL: [email protected] PRODUCT COMPLAINTS BD RECALL SUPPORT CENTER PHONE: 888-562-6018 PHONE HOURS: 7:00AM TO 4:00PM PT, MONDAY ¿ FRIDAY EMAIL: [email protected] RECALL RELATED QUESTIONS TECHNICAL SUPPORT PHONE: 888-812-3229 PHONE HOURS: 6:00AM TO 5:00PM PT, MONDAY ¿ FRIDAY EMAIL: [email protected] TECHNICAL QUESTIONS BD¿S ACTIONS ARE GUIDED BY OUR COMMITMENT TO PATIENT SAFETY AND MINIMIZING DISRUPTION OF PATIENT CARE. WE REGRET THE INCONVENIENCE THAT MAY RESULT FROM THIS RECALL AND ARE COMMITTED TO ACHIEVING THE HIGHEST LEVELS OF CUSTOMER SATISFACTION AND SERVING YOUR INFUSION PRODUCT NEEDS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 29AUG2012 THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. BASED ON THE FINDINGS, TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE PROXIMATE CAUSE OF THE REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR SN (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THERE WERE NO EXISTING CAPA¿S LISTED FOR ANY OF THE PARTS LISTED IN THIS FILE FOR REPAIR. H3 OTHER TEXT : NOT PROVIDED.
IT WAS REPORTED THAT THE DEVICE SHOWED ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.
THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.
IT WAS REPORTED THAT THE DEVICE SHOWED ERROR CODE 570.6200. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73457 | ALARIS ETCO2 | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS | CCK | CAREFUSION SD | 8300 | 10885403830013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |