ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-162187
- Event Type
- Malfunction
- Date Received
- July 14, 2022
- Date of Event
- June 24, 2022
- Report Date
- October 31, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
ADDITIONAL INFORMATION: IMDRF ANNEX A,G,B CODES AND MANUFACTURER NARRATIVE.. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.
OMIT: EVENT ATTRIBUTED TO. CORRECTION: ADVERSE TYPE, DESCRIBE EVENT OR PROBLEM, TYPE OF REPORTABLE EVENTS.
OMIT: A26 - INSUFFICIENT INFORMATION (3190), G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY AND IMDRF ANNEX A, G & C CODES. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.
IT WAS REPORTED THAT A PUMP MODULE WAS PROGRAMMED TO INFUSE HEPARIN WITH AN ORDERED INITIAL RATE OF 12 UNITS/KG/HOUR (9ML/HOUR). EFFECT OF HEPARIN IS MEASURED BY ANTI XA LAB LEVEL WHICH CAME BACK HIGH. PER PROTOCOL, HEPARIN INFUSION WAS HELD 1 HOUR THEN RESTARTED WITH INFUSION RATE REDUCED TO 9 UNITS/KG/HR. EFFECT OF MEDICATION AS MEASURED BY ANTI-XA LEVEL STILL HIGH. INFUSION HELD 1 HOUR THEN RESTARTED WITH RATE REDUCED TO 6 UNITS/KG/H. WHEN ANTI-XA LAB WAS REDRAWN, THE RESULTS WERE STILL HIGH, HOWEVER TRENDING DOWN. PER PROTOCOL, HEPARIN HELD 1 HOUR THEN RESTARTED WITH RATE REDUCED TO 3 UNITS/KG/H. ANTI-XA LEVEL HIGH WHEN LABS WERE DRAWN, ALTHOUGH TRENDING DOWN. INFUSION HELD PER PROTOCOL. ANTI-XA LEVELS CONTINUED TO BE MONITORED. ONCE LEVELS WERE IN A THERAPEUTIC RANGE, PATIENT WAS RESTARTED BACK ON HEPARIN INFUSION AT 2 UNITS/KG/HR. DURING THIS TIME, 2 ANTI-XA LEVELS WERE WITHIN THERAPEUTIC RANGE. CUSTOMER STATES PROGRAMMING AND MEDICATION WERE CONFIRMED TO BE CORRECT. CUSTOMER IS REQUESTING RATE/ACCURACY ANALYSIS BE COMPLETED.
IT WAS REPORTED THAT A PUMP MODULE WAS PROGRAMMED TO INFUSE HEPARIN WITH AN ORDERED INITIAL RATE OF 12 UNITS/KG/HOUR (9ML/HOUR). EFFECT OF HEPARIN IS MEASURED BY ANTI XA LAB LEVEL WHICH CAME BACK HIGH. PER PROTOCOL, HEPARIN INFUSION WAS HELD 1 HOUR THEN RESTARTED WITH INFUSION RATE REDUCED TO 9 UNITS/KG/HR. EFFECT OF MEDICATION AS MEASURED BY ANTI-XA LEVEL STILL HIGH. INFUSION HELD 1 HOUR THEN RESTARTED WITH RATE REDUCED TO 6 UNITS/KG/H. WHEN ANTI-XA LAB WAS REDRAWN, THE RESULTS WERE STILL HIGH, HOWEVER TRENDING DOWN. PER PROTOCOL, HEPARIN HELD 1 HOUR THEN RESTARTED WITH RATE REDUCED TO 3 UNITS/KG/H. ANTI-XA LEVEL HIGH WHEN LABS WERE DRAWN, ALTHOUGH TRENDING DOWN. INFUSION HELD PER PROTOCOL. ANTI-XA LEVELS CONTINUED TO BE MONITORED. ONCE LEVELS WERE IN A THERAPEUTIC RANGE, PATIENT WAS RESTARTED BACK ON HEPARIN INFUSION AT 2 UNITS/KG/HR. DURING THIS TIME, 2 ANTI-XA LEVELS WERE WITHIN THERAPEUTIC RANGE. CUSTOMER STATES PROGRAMMING AND MEDICATION WERE CONFIRMED TO BE CORRECT. CUSTOMER IS REQUESTING RATE/ACCURACY ANALYSIS BE COMPLETED. ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE, THE CUSTOMER HAS NOT RETURNED THE DEVICES FOR INVESTIGATION OR PROVIDE THE LOGS.
IT WAS REPORTED THAT STARTING ON 23 JUNE AT ABOUT 0358, HEPARIN (BLOOD THINNER) DRIP, 100UNITS/ML IN 250ML BAG, WAS BEING INFUSED WITH AN INITIAL RATE OF 12UNITS/KG/HOUR (9ML/HOUR). IT WAS NOTED THAT THE MEDICATION'S EFFECT WAS MEASURED BY ANTI XA LEVELS AND THE RESULT CAME BACK "HIGH (BLOOD TOO THIN)." THE INFUSION WAS THEN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 9UNITS/KG/HR. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS AGAIN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 6UNITS/KG/H. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS AGAIN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 3 UNITS/KG/H. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS HELD AND FOLLOWING THE PROTOCOL, NEXT STEP WAS TO REDUCE TO 0UNITS/KG/HOUR. PER HOSPITAL'S PHARMACY CLINICAL MANAGER, IT APPEARS THAT EITHER THE "PATIENT IS EXTREMELY SENSITIVE TO HEPARIN OR INFUSION IS NOT CORRECT." THE ANTI-XA LEVELS CONTINUED TO BE MONITORED AND ONCE WITHIN THERAPEUTIC RANGE, THE PATIENT WAS RESTARTED ON A HEPARIN DRIP AT UNITS/KG/HR ON 24 JUNE AT 2028 UNTIL 25 JUNE AT 1526. DURING THIS TIME, THERE WERE TWO (2) ANTI-XA LEVELS THAT CAME BACK WITHIN THERAPEUTIC RANGE. THE HOSPITAL'S PHARMACY CLINICAL MANAGER CHECKED THE ¿ALL INFUSION DETAIL¿ REPORT IN BD KNOWLEDGE PORTAL AND IT APPEARS THE PROGRAMING WAS DONE CORRECTLY. THE CUSTOMER ALSO CHECKED THE MEDICATION AND IT IS CORRECT (HEPARIN 100UNITS/ML). NO CONCURRENT INFUSIONS RUNNING AT THAT TIME, THE DATASET WAS CORRECT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM OR INJURY.
IT WAS REPORTED THAT STARTING ON 23 JUNE AT ABOUT 0358, HEPARIN (BLOOD THINNER) DRIP, 100UNITS/ML IN 250ML BAG, WAS BEING INFUSED WITH AN INITIAL RATE OF 12UNITS/KG/HOUR (9ML/HOUR). IT WAS NOTED THAT THE MEDICATION'S EFFECT WAS MEASURED BY ANTI XA LEVELS AND THE RESULT CAME BACK "HIGH (BLOOD TOO THIN)." THE INFUSION WAS THEN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 9UNITS/KG/HR. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS AGAIN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 6UNITS/KG/H. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS AGAIN HELD FOR ONE (1) HOUR THEN RESTARTED WITH RATE REDUCED TO 3 UNITS/KG/H. THE ANTI-XA LEVEL WAS MEASURED AGAIN AND THE RESULT WAS STILL "HIGH." THE INFUSION WAS HELD AND FOLLOWING THE PROTOCOL, NEXT STEP WAS TO REDUCE TO 0UNITS/KG/HOUR. PER HOSPITAL'S PHARMACY CLINICAL MANAGER, IT APPEARS THAT EITHER THE "PATIENT IS EXTREMELY SENSITIVE TO HEPARIN OR INFUSION IS NOT CORRECT." THE ANTI-XA LEVELS CONTINUED TO BE MONITORED AND ONCE WITHIN THERAPEUTIC RANGE, THE PATIENT WAS RESTARTED ON A HEPARIN DRIP AT UNITS/KG/HR ON (B)(6) 2028 UNTIL (B)(6) AT 1526. DURING THIS TIME, THERE WERE TWO (2) ANTI-XA LEVELS THAT CAME BACK WITHIN THERAPEUTIC RANGE. THE HOSPITAL'S PHARMACY CLINICAL MANAGER CHECKED THE ¿ALL INFUSION DETAIL¿ REPORT IN BD KNOWLEDGE PORTAL AND IT APPEARS THE PROGRAMING WAS DONE CORRECTLY. THE CUSTOMER ALSO CHECKED THE MEDICATION AND IT IS CORRECT (HEPARIN 100UNITS/ML). NO CONCURRENT INFUSIONS RUNNING AT THAT TIME, THE DATASET WAS CORRECT. THE CUSTOMER STATED THAT THERE WAS NO PATIENT HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408208 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | Required Intervention | 8015 |