ABACUS V2.0 TPN CALCULATING SOFTWARE
Report
- Report Number
- 1419106-2008-00015
- Event Type
- Other
- Date Received
- December 18, 2008
- Manufacturer
- BAXA CORP.
- Product Code
- LNX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHARMACIST
Narratives
AN EVALUATION OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED CALCIUM GLUCONATE AS ORDERED IN ABACUS (63/73 ML, 72.02 ML, 110.8 ML AND 98.22 ML). THE MIXCHECK REPORTS INDICATE THAT THE TOTAL COMPOUNDED VOLUMES OF THE SUBJECT BAGS WERE ACCURATELY DELIVERED WITHIN ACCEPTABLE RANGE (+/-3% OF THE ORDERED VOLUMES). RESULTS OF EVALUATION: THE ABACUS DATABASE REVEALED THAT THIS FACILITY USED AN ION-BASED ORDERED TEMPLATE FOR THE SUBJECT ORDERS. AT 08:41 IN 2008, PHARMACIST A ALTERED THE CALCIUM GLUCONATE SALT INGREDIENT WITHIN THE FORMULARY, CHANGING THE CONCENTRATION FROM 100MG/DML TO 0.465MEQ/ML AND THE ELEMENTAL CALCIUM ION CONCENTRATION FROM 100MG/ML TO 0.465MEQ/ML. WHEN THE FORMULARY CHANGES WERE COMPLETE, TWO TEST ORDERS WERE ENTERED AND COMPLETED. BEGINNING AT 09:25, PHARMACIST B, C AND D BEGAN ENTERING AND ARRIVING PRODUCTION ORDERS USING THE EXISTING TEMPLATE THAT WAS BUILT FOR ORDERING THE CALCIUM GLUCONATE SALT, WHILE THE FORMULARY CONCENTRATIONS WERE CHANGED TO ACCOMMODATE CALCIUM ION BASED ORDERING (0.465MEQ/ML). THE FORMULARY WAS REVERTED BACK TO CONCENTRATIONS REFLECTING THE CALCIUM GLUCONATE SALT AT 13:08 ON 11/15/2008. AS A RESULT, THE SUBJECT ORDERS WERE PROCESSED WITH APPROX. 10.75 TIMES MORE CALCIUM GLUCONATE AS INTENDED. THE ABACUS DATABASE SHOWED THAT THE SOFTWARE DISPLAYED A WARNING THAT THE CALCIUM PHOSPHATE SOLUBILITY GRAPH WAS BLUE FOR EACH SUBJECT ORDER INDICATING THAT THE CA/PO4 POINT HAD A VALUE THAT DOES NOT PERMIT INTERPRETATION, BECAUSE IT IS EITHER OFF THE SCALE OR DOES NOT HAVE AN INTERCEPT WITH THE GRAPHS THAT ARE SHOWN ON THE SCREEN. THE TRAINING RECORD FOR THIS FACILITY WAS REVIEWED; THE USER SIGNED THAT THEY UNDERSTOOD THAT TEMPLATES MAY BE CREATED FOR SALT BASED ORDERING OR ION BASED ORDERING BUT NOT A COMBINATION OF BOTH SALTS AND IONS; THE USER ALSO SIGNED THAT THEY UNDERSTOOD WARNING LIMIT IMPLEMENTATION AND THE THREE DEFAULT ALARM LEVELS RESIDENT IN THE ABACUS SOFTWARE AT THE TIME OF INSTALLATION. THE BLACK BOX DATA FOR THE MICROMACRO 12 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE BLACK BOX SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM GLUCONATE AS ORDERED. BASED ON AN EVALUATION OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE HIGHER-THAN-ANTICIPATED VOLUME OF CALCIUM GLUCONATE WAS THE RESULT OF THE USER CHANGING THE CALCIUM GLUCONATE SALT CONCENTRATION AND THE ELEMENTAL CALCIUM ION CONCENTRATION WITHIN THE FORMULARY FOR TESTING PURPOSES BUT DID NOT REVERT THESE VALUES BEFORE CONTINUING WITH PRODUCTION. INVESTIGATION HAS CONFIRMED THAT THE ABACUS SOFTWARE AND MICROMACRO 12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE AMOUNT OF CALCIUM GLUCONATE AS ORDERED IN THE ABACUS SOFTWARE.
ON 11/18/2008, BAXA WAS NOTIFIED BY THE CUSTOMER OF FOUR PATIENT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-ANTICIPATED VOLUME OF THE CALCIUM GLUCONATE INGREDIENT. INFUSION WAS TERMINATED AFTER THE PATIENT SHOW SYMPTOMS OF SOFT TISSUE CALCIFICATION. LASIX, PHOSPHATE AND HYLERLONDAISE WERE ADMINISTERED TO FACILITATE BINDING OUT THE CALCIUM FROM THE TISSUE OF THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
AN EVALUATION OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED CALCIUM GLUCONATE AS ORDERED IN ABACUS (63/73 ML, 72.02 ML, 110.8 ML AND 98.22 ML). THE MIXCHECK REPORTS INDICATE THAT THE TOTAL COMPOUNDED VOLUMES OF THE SUBJECT BAGS WERE ACCURATELY DELIVERED WITHIN ACCEPTABLE RANGE (+/-3% OF THE ORDERED VOLUMES). RESULTS OF EVALUATION: THE ABACUS DATABASE REVEALED THAT THIS FACILITY USED AN ION-BASED ORDERED TEMPLATE FOR THE SUBJECT ORDERS. AT 08:41 IN 2008, PHARMACIST A ALTERED THE CALCIUM GLUCONATE SALT INGREDIENT WITHIN THE FORMULARY, CHANGING THE CONCENTRATION FROM 100MG/DML TO 0.465MEQ/ML AND THE ELEMENTAL CALCIUM ION CONCENTRATION FROM 100MG/ML TO 0.465MEQ/ML. WHEN THE FORMULARY CHANGES WERE COMPLETE, TWO TEST ORDERS WERE ENTERED AND COMPLETED. BEGINNING AT 09:25, PHARMACIST B, C AND D BEGAN ENTERING AND ARRIVING PRODUCTION ORDERS USING THE EXISTING TEMPLATE THAT WAS BUILT FOR ORDERING THE CALCIUM GLUCONATE SALT, WHILE THE FORMULARY CONCENTRATIONS WERE CHANGED TO ACCOMMODATE CALCIUM ION BASED ORDERING (0.465MEQ/ML). THE FORMULARY WAS REVERTED BACK TO CONCENTRATIONS REFLECTING THE CALCIUM GLUCONATE SALT AT 13:08 TWO DAYS LATER. AS A RESULT, THE SUBJECT ORDERS WERE PROCESSED WITH APPROX. 10.75 TIMES MORE CALCIUM GLUCONATE AS INTENDED. THE ABACUS DATABASE SHOWED THAT THE SOFTWARE DISPLAYED A WARNING THAT THE CALCIUM PHOSPHATE SOLUBILITY GRAPH WAS BLUE FOR EACH SUBJECT ORDER INDICATING THAT THE CA/PO4 POINT HAD A VALUE THAT DOES NOT PERMIT INTERPRETATION, BECAUSE IT IS EITHER OFF THE SCALE OR DOES NOT HAVE AN INTERCEPT WITH THE GRAPHS THAT ARE SHOWN ON THE SCREEN. THE TRAINING RECORD FOR THIS FACILITY WAS REVIEWED; THE USER SIGNED THAT THEY UNDERSTOOD THAT TEMPLATES MAY BE CREATED FOR SALT BASED ORDERING OR ION BASED ORDERING BUT NOT A COMBINATION OF BOTH SALTS AND IONS; THE USER ALSO SIGNED THAT THEY UNDERSTOOD WARNING LIMIT IMPLEMENTATION AND THE THREE DEFAULT ALARM LEVELS RESIDENT IN THE ABACUS SOFTWARE AT THE TIME OF INSTALLATION. THE BLACK BOX DATA FOR THE MICROMACRO 12 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE BLACK BOX SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM GLUCONATE AS ORDERED. BASED ON AN EVALUATION OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE HIGHER-THAN-ANTICIPATED VOLUME OF CALCIUM GLUCONATE WAS THE RESULT OF THE USER CHANGING THE CALCIUM GLUCONATE SALT CONCENTRATION AND THE ELEMENTAL CALCIUM ION CONCENTRATION WITHIN THE FORMULARY FOR TESTING PURPOSES BUT DID NOT REVERT THESE VALUES BEFORE CONTINUING WITH PRODUCTION. INVESTIGATION HAS CONFIRMED THAT THE ABACUS SOFTWARE AND MICROMACRO 12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE AMOUNT OF CALCIUM GLUCONATE AS ORDERED IN THE ABACUS SOFTWARE.
ON 11/18/2008, BAXA WAS NOTIFIED BY THE CUSTOMER OF FOUR PATIENT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-ANTICIPATED VOLUME OF THE CALCIUM GLUCONATE INGREDIENT. INFUSION WAS TERMINATED AFTER THE PATIENT SHOW SYMPTOMS OF SOFT TISSUE CALCIFICATION. LASIX, PHOSPHATE AND HYLERLONDAISE WERE ADMINISTERED TO FACILITATE BINDING OUT THE CALCIUM FROM THE TISSUE OF THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
AN EVALUATION OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED CALCIUM GLUCONATE AS ORDERED IN ABACUS (63.73 ML, 72.02 ML, 110.8 ML AND 98.22 ML). THE MIXCHECK REPORTS INDICATE THAT THE TOTAL COMPOUNDED VOLUMES OF THE SUBJECT BAGS WERE ACCURATELY DELIVERED WITHIN ACCEPTABLE RANGE (+/-3% OF THE ORDERED VOLUMES). RESULTS OF EVALUATION: THE ABACUS DATABASE REVEALED THAT THIS FACILITY USED AN ION-BASED ORDERED TEMPLATE FOR THE SUBJECT ORDERS. AT 08:41 IN 2008, PHARMACIST A ALTERED THE CALCIUM GLUCONATE SALT INGREDIENT WITHIN THE FORMULARY, CHANGING THE CONCENTRATION FROM 100MG/DML TO 0.465MEQ/ML AND THE ELEMENTAL CALCIUM ION CONCENTRATION FROM 100MG/ML TO 0.465MEQ/ML. WHEN THE FORMULARY CHANGES WERE COMPLETE, TWO TEST ORDERS WERE ENTERED AND COMPLETED. BEGINNING AT 09:25, PHARMACIST B, C AND D BEGAN ENTERING AND ARRIVING PRODUCTION ORDERS USING THE EXISTING TEMPLATE THAT WAS BUILT FOR ORDERING THE CALCIUM GLUCONATE SALT, WHILE THE FORMULARY CONCENTRATIONS WERE CHANGED TO ACCOMMODATE CALCIUM ION BASED ORDERING (0.465MEQ/ML). THE FORMULARY WAS REVERTED BACK TO CONCENTRATIONS REFLECTING THE CALCIUM GLUCONATE SALT AT 13:08 TWO DAYS LATER. AS A RESULT, THE SUBJECT ORDERS WERE PROCESSED WITH APPROX 10.75 TIMES MORE CALCIUM GLUCONATE AS INTENDED. THE ABACUS DATABASE SHOWED THAT THE SOFTWARE DISPLAYED A WARNING THAT THE CALCIUM PHOSPHATE SOLUBILITY GRAPH WAS BLUE FOR EACH SUBJECT ORDER INDICATING THAT THE CA/PO4 POINT HAD A VALUE THAT DOES NOT PERMIT INTERPRETATION, BECAUSE IT IS EITHER OFF THE SCALE OR DOES NOT HAVE AN INTERCEPT WITH THE GRAPHS THAT ARE SHOWN ON THE SCREEN. THE TRAINING RECORD FOR THIS FACILITY WAS REVIEWED; THE USER SIGNED THAT THEY UNDERSTOOD THAT TEMPLATES MAY BE CREATED FOR SALT BASED ORDERING OR ION BASED ORDERING BUT NOT A COMBINATION OF BOTH SALTS AND IONS; THE USER ALSO SIGNED THAT THEY UNDERSTOOD WARNING LIMIT IMPLEMENTATION AND THE THREE DEFAULT ALARM LEVELS RESIDENT IN THE ABACUS SOFTWARE AT THE TIME OF INSTALLATION. THE BLACK BOX DATA FOR THE MICROMACRO 12 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE BLACK BOX SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM GLUCONATE AS ORDERED. BASED ON AN EVALUATION OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE HIGHER-THAN-ANTICIPATED VOLUME OF CALCIUM GLUCONATE WAS THE RESULT OF THE USER CHANGING THE CALCIUM GLUCONATE SALT CONCENTRATION AND THE ELEMENTAL CALCIUM ION CONCENTRATION WITHIN THE FORMULARY FOR TESTING PURPOSES BUT DID NOT REVERT THESE VALUES BEFORE CONTINUING WITH PRODUCTION. INVESTIGATION HAS CONFIRMED THAT THE ABACUS SOFTWARE AND MICROMACRO 12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE AMOUNT OF CALCIUM GLUCONATE AS ORDERED IN THE ABACUS SOFTWARE.
ON 11/18/2008, BAXA WAS NOTIFIED BY THE CUSTOMER OF FOUR PATIENT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-ANTICIPATED VOLUME OF THE CALCIUM GLUCONATE INGREDIENT. INFUSION WAS TERMINATED AFTER THE PATIENT SHOW SYMPTOMS OF SOFT TISSUE CALCIFICATION. LASIX, PHOSPHATE AND HYLERLONDAISE WERE ADMINISTERED TO FACILITATE BINDING OUT THE CALCIUM FROM THE TISSUE OF THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
AN EVALUATION OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED CALCIUM GLUCONATE AS ORDERED IN ABACUS (63/73 ML, 72.02 ML, 110.8 ML AND 98.22 ML). THE MIXCHECK REPORTS INDICATE THAT THE TOTAL COMPOUNDED VOLUMES OF THE SUBJECT BAGS WERE ACCURATELY DELIVERED WITHIN ACCEPTABLE RANGE (+/-3% OF THE ORDERED VOLUMES). RESULTS OF EVALUATION: THE ABACUS DATABASE REVEALED THAT THIS FACILITY USED AN ION-BASED ORDERED TEMPLATE FOR THE SUBJECT ORDERS. AT 08:41 IN 2008, PHARMACIST A ALTERED THE CALCIUM GLUCONATE SALT INGREDIENT WITHIN THE FORMULARY, CHANGING THE CONCENTRATION FROM 100MG/DML TO 0.465MEQ/ML AND THE ELEMENTAL CALCIUM ION CONCENTRATION FROM 100MG/ML TO 0.465MEQ/ML. WHEN THE FORMULARY CHANGES WERE COMPLETE, TWO TEST ORDERS WERE ENTERED AND COMPLETED. BEGINNING AT 09:25, PHARMACIST B, C AND D BEGAN ENTERING AND ARRIVING PRODUCTION ORDERS USING THE EXISTING TEMPLATE THAT WAS BUILT FOR ORDERING THE CALCIUM GLUCONATE SALT, WHILE THE FORMULARY CONCENTRATIONS WERE CHANGED TO ACCOMMODATE CALCIUM ION BASED ORDERING (0.465MEQ/ML). THE FORMULARY WAS REVERTED BACK TO CONCENTRATIONS REFLECTING THE CALCIUM GLUCONATE SALT AT 13:08 TWO DAYS LATER. AS A RESULT, THE SUBJECT ORDERS WERE PROCESSED WITH APPROX. 10.75 TIMES MORE CALCIUM GLUCONATE AS INTENDED. THE ABACUS DATABASE SHOWED THAT THE SOFTWARE DISPLAYED A WARNING THAT THE CALCIUM PHOSPHATE SOLUBILITY GRAPH WAS BLUE FOR EACH SUBJECT ORDER INDICATING THAT THE CA/PO4 POINT HAD A VALUE THAT DOES NOT PERMIT INTERPRETATION, BECAUSE IT IS EITHER OFF THE SCALE OR DOES NOT HAVE AN INTERCEPT WITH THE GRAPHS THAT ARE SHOWN ON THE SCREEN. THE TRAINING RECORD FOR THIS FACILITY WAS REVIEWED; THE USER SIGNED THAT THEY UNDERSTOOD THAT TEMPLATES MAY BE CREATED FOR SALT BASED ORDERING OR ION BASED ORDERING BUT NOT A COMBINATION OF BOTH SALTS AND IONS; THE USER ALSO SIGNED THAT THEY UNDERSTOOD WARNING LIMIT IMPLEMENTATION AND THE THREE DEFAULT ALARM LEVELS RESIDENT IN THE ABACUS SOFTWARE AT THE TIME OF INSTALLATION. THE BLACK BOX DATA FOR THE MICROMACRO 12 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE BLACK BOX SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM GLUCONATE AS ORDERED. BASED ON AN EVALUATION OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE HIGHER-THAN-ANTICIPATED VOLUME OF CALCIUM GLUCONATE WAS THE RESULT OF THE USER CHANGING THE CALCIUM GLUCONATE SALT CONCENTRATION AND THE ELEMENTAL CALCIUM ION CONCENTRATION WITHIN THE FORMULARY FOR TESTING PURPOSES BUT DID NOT REVERT THESE VALUES BEFORE CONTINUING WITH PRODUCTION. INVESTIGATION HAS CONFIRMED THAT THE ABACUS SOFTWARE AND MICROMACRO 12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE AMOUNT OF CALCIUM GLUCONATE AS ORDERED IN THE ABACUS SOFTWARE.
ON 11/18/2008, BAXA WAS NOTIFIED BY THE CUSTOMER OF FOUR PATIENT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-ANTICIPATED VOLUME OF THE CALCIUM GLUCONATE INGREDIENT. INFUSION WAS TERMINATED AFTER THE PATIENT SHOW SYMPTOMS OF SOFT TISSUE CALCIFICATION. LASIX, PHOSPHATE AND HYLERLONDAISE WERE ADMINISTERED TO FACILITATE BINDING OUT THE CALCIUM FROM THE TISSUE OF THE PATIENT. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABACUS V2.0 TPN CALCULATING SOFTWARE | ABACUS SINGLE WORKSTATION | LNX | BAXA CORP. | 8300-0046 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | ||
| 2 | UNKNOWN | Required Intervention | ||
| 3 | UNKNOWN | Required Intervention | ||
| 4 | UNKNOWN | Required Intervention |