EXACTA-MIX 2400
Report
- Report Number
- 1419106-2009-00009
- Event Type
- Other
- Date Received
- May 11, 2009
- Date of Event
- April 7, 2009
- Report Date
- April 14, 2009
- Manufacturer
- BAXA CORP.
- Product Code
- NEP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHARMACIST
Narratives
THE CUSTOMER WAS ABLE TO PROVIDE THEIR EM2400 COMPOUNDER DATABASE AND BLACKBOX DATA, AS WELL AS THEIR ABACUS DATABASE AND COPIES OF LABELS PRODUCED BY ABACUS FOR THE SUBJECT BAGS. THE CUSTOMER DID NOT PROVIDE THE PRESCRIBER ORDERS FOR THESE BAGS. AN EVAL OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED DEXTROSE AS ORDERED IN ABACUS (87.22 ML FOR PT #1, AND 38.43 ML FOR PT #2). IT WAS ALSO DETERMINED THAT THE MIXCHECK REPORT INDICATES THAT THE TOTAL COMPOUNDED VOLUME OF THE SUBJECT BAGS WERE WITHIN +/-3% OF THE ORDERED VOLUME (ACTUAL % DIFFERENCE: -0.51% FOR PT #1, AND -0.66% FOR PT #2). THE INFO PROVIDED BY THE CUSTOMER STATES THAT THE BAG FOR PT #2 HAD A GLUCOSE LEVEL OF 0.5% INSTEAD OF 12.5% ACCORDING TO THE FACILITY LAB RESULTS. THIS WOULD INDICATE A DELIVERY OF 1.535 ML OF DEXTROSE 70% FOR THE ENTIRE BAG, WHICH WOULD BE A TOTAL COMPOUNDED VOLUME OF -11.4% OF THE ORDERED VOLUME. HOWEVER, THE TOTAL WEIGHT DIFFERENCE FOR THIS SUBJECT BAG WAS -0.66%. THE CUSTOMER DID NOT PROVIDE THE LABORATORY TESTS RESULTS. THEREFORE, THE ACCURACY OF THIS FACILITY'S LABORATORY TESTING IS UNK. THE PRUDENT COURSE OF ACTION WOULD BE TO REPEAT THE LABORATORY TEST TO ENSURE THAT THE VALUE WHICH WAS FIRST REPORTED WAS ACCURATE. IF THE MACHINE WERE TO GO OUTSIDE ITS CALIBRATED RANGE, THE ACCURACY DROPS. THE MACHINE USED FOR TESTING THE GLUCOSE CONCENTRATION NEEDS TO BE CABLE OF READING THE RANGE OF COMPLEX TPN SOLUTIONS. THE METHOD USED TO TEST THE RESERVOIR SAMPLES OF THE SUBJECT BAGS WAS NOT PROVIDED. AN EXAMINATION OF THE EM2400 BLACKBOX DATA AND ABACUS DATABASE SHOW NO UNUSUAL EVENTS IN THE DEVICE HISTORY OR INFO THAT MIGHT RELATE TO THE REPORTED INCIDENTS. THROUGH OUR INVESTIGATION, WE DO NOT HAVE INFO SUGGESTING THAT THE EM2400 COMPOUNDER OR ABACUS CALCULATING SOFTWARE CAUSED OR CONTRIBUTED TO THESE INCIDENTS AS A RESULT OF FAILURE, MALFUNCTION, IMPROPER OR INADEQUATE DESIGN, MANUFACTURE, OR LABELING OF THE PRODUCT. A CONFERENCE CALL WAS CONDUCTED ON (B)(4) 2009 WITH THE FACILITY ASST DIRECTOR OF PHARMACY AND BAXA ASSOCIATES TO DISCUSS THE RESULTS OF THE DATA EVAL. TO PREVENT ANY RE-OCCURRING INCIDENTS, ALL PRODUCT MANUFACTURED IN THE FACILITY IV ROOM WILL BE TESTED PRIOR TO USE. IF BAXA RECEIVES ADD'L INFO IN REGARDS TO THIS INCIDENT, A F/U MDR WILL BE SUBMITTED.
ON (B)(6) 2009, BAXA WAS NOTIFIED BY THE CUSTOMER OF TWO PT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE AND THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PT HAD RECEIVED A TPN BAG ON (B)(6) 2009 CONTAINING A LOWER-THAN-ANTICIPATED VOLUME OF THE DEXTROSE INGREDIENT. A SAMPLE FROM THE RESERVOIR WAS SENT TO THE LAB AND THE GLUCOSE LEVEL INDICATED 14.7% INSTEAD OF 17.7%. THE PT'S BLOOD WORK INDICATED THAT THE BLOOD SUGAR LEVELS HAD DROPPED TO 46. DEXTROSE BOLUS WAS ADMINISTERED TO RAISE THE GLUCOSE LEVEL TO 124. THE PT'S CURRENT STATUS IS STABLE WITH NO APPARENT LONG-TERM INJURY OR ILLNESS RESULTING FROM THIS ISSUE.
THE CUSTOMER WAS ABLE TO PROVIDE THEIR EM2400 COMPOUNDER DATABASE AND BLACKBOX DATA, AS WELL AS THEIR ABACUS DATABASE AND COPIES OF LABELS PRODUCED BY ABACUS FOR THE SUBJECT BAGS. THE CUSTOMER DID NOT PROVIDE THE PRESCRIBER ORDERS FOR THESE BAGS. AN EVAL OF THE COMPOUNDER MIXCHECK REPORTS AND THE ABACUS SOLUTION LABELS FOR THE SUBJECT BAGS INDICATES THAT THE COMPOUNDER DELIVERED DEXTROSE AS ORDERED IN ABACUS (87.22 ML FOR PT #1, AND 38.43 ML FOR PT #2). IT WAS ALSO DETERMINED THAT THE MIXCHECK REPORT INDICATES THAT THE TOTAL COMPOUNDED VOLUME OF THE SUBJECT BAGS WERE WITHIN +/-3% OF THE ORDERED VOLUME (ACTUAL % DIFFERENCE: -0.51% FOR PT #1, AND -0.66% FOR PT #2). THE INFO PROVIDED BY THE CUSTOMER STATES THAT THE BAG FOR PT #2 HAD A GLUCOSE LEVEL OF 0.5% INSTEAD OF 12.5% ACCORDING TO THE FACILITY LAB RESULTS. THIS WOULD INDICATE A DELIVERY OF 1.535 ML OF DEXTROSE 70% FOR THE ENTIRE BAG, WHICH WOULD BE A TOTAL COMPOUNDED VOLUME OF -11.4% OF THE ORDERED VOLUME. HOWEVER, THE TOTAL WEIGHT DIFFERENCE FOR THIS SUBJECT BAG WAS -0.66%. THE CUSTOMER DID NOT PROVIDE THE LABORATORY TESTS RESULTS. THEREFORE, THE ACCURACY OF THIS FACILITY'S LABORATORY TESTING IS UNK. THE PRUDENT COURSE OF ACTION WOULD BE TO REPEAT THE LABORATORY TEST TO ENSURE THAT THE VALUE WHICH WAS FIRST REPORTED WAS ACCURATE. IF THE MACHINE WERE TO GO OUTSIDE ITS CALIBRATED RANGE, THE ACCURACY DROPS. THE MACHINE USED FOR TESTING THE GLUCOSE CONCENTRATION NEEDS TO BE CABLE OF READING THE RANGE OF COMPLEX TPN SOLUTIONS. THE METHOD USED TO TEST THE RESERVOIR SAMPLES OF THE SUBJECT BAGS WAS NOT PROVIDED. AN EXAMINATION OF THE EM2400 BLACKBOX DATA AND ABACUS DATABASE SHOW NO UNUSUAL EVENTS IN THE DEVICE HISTORY OR INFO THAT MIGHT RELATE TO THE REPORTED INCIDENTS. THROUGH OUR INVESTIGATION, WE DO NOT HAVE INFO SUGGESTING THAT THE EM2400 COMPOUNDER OR ABACUS CALCULATING SOFTWARE CAUSED OR CONTRIBUTED TO THESE INCIDENTS AS A RESULT OF FAILURE, MALFUNCTION, IMPROPER OR INADEQUATE DESIGN, MANUFACTURE, OR LABELING OF THE PRODUCT. A CONFERENCE CALL WAS CONDUCTED ON (B)(4) 2009 WITH THE FACILITY ASST DIRECTOR OF PHARMACY AND BAXA ASSOCIATES TO DISCUSS THE RESULTS OF THE DATA EVAL. TO PREVENT ANY RE-OCCURRING INCIDENTS, ALL PRODUCT MANUFACTURED IN THE FACILITY IV ROOM WILL BE TESTED PRIOR TO USE. IF BAXA RECEIVES ADD'L INFO IN REGARDS TO THIS INCIDENT, A F/U MDR WILL BE SUBMITTED.
ON (B)(6) 2009, BAXA WAS NOTIFIED BY THE CUSTOMER OF TWO PT INVOLVED INCIDENTS USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE AND THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PT HAD RECEIVED A TPN BAG ON (B)(6) 2009 CONTAINING A LOWER-THAN-ANTICIPATED VOLUME OF THE DEXTROSE INGREDIENT. A SAMPLE FROM THE RESERVOIR WAS SENT TO THE LAB AND THE GLUCOSE LEVEL INDICATED 14.7% INSTEAD OF 17.7%. THE PT'S BLOOD WORK INDICATED THAT THE BLOOD SUGAR LEVELS HAD DROPPED TO 46. DEXTROSE BOLUS WAS ADMINISTERED TO RAISE THE GLUCOSE LEVEL TO 124. THE PT'S CURRENT STATUS IS STABLE WITH NO APPARENT LONG-TERM INJURY OR ILLNESS RESULTING FROM THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXACTA-MIX 2400 | EXACTA-MIX 2400 | NEP | BAXA CORP. | EM 2400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 DA | Required Intervention | ||
| 2 | 1 DA | Required Intervention |