ALARIS SYSTEM
Report
- Report Number
- 2016493-2025-62125
- Event Type
- Injury
- Date Received
- February 18, 2025
- Date of Event
- November 6, 2024
- Report Date
- December 10, 2025
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2718-2020
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION: UNIQUE DEVICE IDENTIFIER (UDI)#, MEDICAL DEVICE SERIAL #, DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, CONCOMITANT MED PROD DATA, DEVICE EVAL BY MANUFACTURER? DEVICE MANUFACTURE DATE, IMDRF ANNEX A, B, C, D, G CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE REPORT OF AN OVER INFUSION OF MAGNESIUM SULF L&D WAS NOT ABLE TO BE CONFIRMED FROM THE LOG ANALYSIS OR COULD BE REPLICATED DURING DEVICE TESTING. ¿ THE INSPECTION AND TESTING PROCESS DID NOT FIND ANY EXISTING MALFUNCTIONS. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS WITH NO OBSERVANCES OF UNREGULATED FLOW OCCURRING. THE SEAR WAS ALSO FOUND TO BE PROPERLY CLOSING THE ADMINISTRATION SET SAFETY CLAMP WHEN THE DOOR WAS OPENED ¿ AFTER UNREGULATED FLOW TESTING, THE SUSPECT PUMP MODULE WAS PROGRAMMED TO PERFORM A ONE-HOUR SYSTEM LEVEL RATE ACCURACY TEST AT THE INCIDENT INFUSION RATE OF 300ML/HR AND TEST RESULTS MEASURED THE ACTUAL RATE AT 290.58 ML/HR (-3.14% ERROR) INDICATING THE DEVICE IS WITHIN SPECIFICATION AFTER RATE CALIBRATION HAVING NO INCIDENTS OF UNREGULATED FLOW OCCURRING DURING THE TESTING. ¿ NO ERRORS WERE OBSERVED ON BOTH PCU AND SUSPECT PUMP MODULE ON THE REPORTED DATE OF THE EVENT. REVIEW OF THE SUSPECT PUMP MODULE ERROR LOG SHOWED NO MALFUNCTIONS RELEVANT TO THE FACILITY¿S COMPLAINT. ¿ THE PCU EVENT LOG REVEALS THAT THE SUSPECT PUMP MODULE WAS PROGRAMMED ON 06NOV2024 AT 10:03 PM TO INFUSE MAGNESIUM SULFATE AT 300 ML/H, WITH A DOSE OF 2 G/H AND A TARGET VOLUME OF 200 ML. THE INFUSION BEGAN AT 10:06 PM, WAS PAUSED AT 10:26 PM AFTER A PRIMARY VOLUME INFUSED (PVI) OF 102.096 ML AND RESTARTED UNTIL 10:29 PM. THE OPERATOR PAUSED IT AGAIN AT 10:32 PM, SHOWING A TOTAL VOLUME INFUSED (TVI) OF 118.457 ML ¿ DURING THE EXTERNAL INSPECTION OF THE AS-RECEIVED DEVICES, IT WAS FOUND THAT THE PIVOT LATCH SCREW, SEAR, AND BATTERY WERE THIRD-PARTY PARTS. A MEDICAL DEVICE SAFETY ALERT MMS-21-4263-US) WAS SENT OUT ON 7 FEBRUARY 2022, WARNING FACILITIES TO ONLY USE BD-APPROVED PARTS WHEN PERFORMING CORRECTIVE MAINTENANCE OR REPAIRS. THE USE OF THIRD-PARTY PARTS CAN AFFECT THE SAFETY AND EFFICACY OF THE BD ALARIS AND ALARIS DEVICES, LEADING TO DEVICE FAILURE, PATIENT INJURY, OR EVEN DEATH. O FACILITIES HAVE BEEN INFORMED BY THE THIRD-PARTY PARTS NOTICE, DATED FEBRUARY 07, 2022, THAT ONLY ORIGINAL BD PARTS AND COMPONENTS ARE TO BE USED IN ANY MAINTENANCE, REPAIR, OR USE WITH BD DEVICES. O BD HAS NOT TESTED NOR VALIDATED THE PERFORMANCE AND FUNCTIONALITY OF ITS MEDICAL DEVICES WHEN USED WITH REPLACEMENT PARTS MANUFACTURED/REFURBISHED AND SOLD BY THIRD PARTIES AND STRONGLY RECOMMENDS NOT USING ANY THIRD-PARTY COMPONENTS FOR THE MAINTENANCE, SERVICE, AND REPAIR OF BD DEVICES EXCEPT AS EXPLICITLY STATED OTHERWISE. ¿ THE ADMINISTRATION SET WAS REQUESTED BUT WAS NOT RETURNED; THEREFORE, IT COULD NOT BE INSPECTED OR TESTED. ¿ THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTION. THE MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DESIGNATED COMPLAINT HANDLING UNIT (DCHU), REPAIR CENTER OR THE CUSTOMER. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE FOR THE REPORT OF OVER INFUSION OF MAGNESIUM WAS NOT ABLE TO BE IDENTIFIED FROM THE LOG ANALYSIS OR FROM DEVICE LABORATORY TESTING. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION, AND THE SEAR WAS FOUND TO BE PROPERLY CLOSING THE SAFETY CLAMP WHEN THE ADMINISTRATION SET IS REMOVED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A0401, A1801, A0406, G02017, G0405206, G04100, G07001, C0601, D15, D0106 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
OMIT: D01 - CAUSE TRACED TO DEVICE DESIGN. ADDITIONAL INFORMATION: IMDRF D CODES AND MANUFACTURER NARRATIVE. 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. INVESTIGATION SUMMARY: THE REPORT OF AN OVER INFUSION OF MAGNESIUM SULF L&D WAS NOT ABLE TO BE CONFIRMED FROM THE LOG ANALYSIS OR COULD BE REPLICATED DURING DEVICE TESTING. THE INSPECTION AND TESTING PROCESS DID NOT FIND ANY EXISTING MALFUNCTIONS. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATIONS WITH NO OBSERVANCES OF UNREGULATED FLOW OCCURRING. THE SEAR WAS ALSO FOUND TO BE PROPERLY CLOSING THE ADMINISTRATION SET SAFETY CLAMP WHEN THE DOOR WAS OPENED AFTER UNREGULATED FLOW TESTING, THE SUSPECT PUMP MODULE WAS PROGRAMMED TO PERFORM A ONE-HOUR SYSTEM LEVEL RATE ACCURACY TEST AT THE INCIDENT INFUSION RATE OF 300ML/HR AND TEST RESULTS MEASURED THE ACTUAL RATE AT 290.58 ML/HR (-3.14% ERROR) INDICATING THE DEVICE IS WITHIN SPECIFICATION AFTER RATE CALIBRATION HAVING NO INCIDENTS OF UNREGULATED FLOW OCCURRING DURING THE TESTING. NO ERRORS WERE OBSERVED ON BOTH PCU AND SUSPECT PUMP MODULE ON THE REPORTED DATE OF THE EVENT. REVIEW OF THE SUSPECT PUMP MODULE ERROR LOG SHOWED NO MALFUNCTIONS RELEVANT TO THE FACILITY¿S COMPLAINT. THE PCU EVENT LOG REVEALS THAT THE SUSPECT PUMP MODULE WAS PROGRAMMED ON 06NOV2024 AT 10:03 PM TO INFUSE MAGNESIUM SULFATE AT 300 ML/H, WITH A DOSE OF 2 G/H AND A TARGET VOLUME OF 200 ML. THE INFUSION BEGAN AT 10:06 PM, WAS PAUSED AT 10:26 PM AFTER A PRIMARY VOLUME INFUSED (PVI) OF 102.096 ML AND RESTARTED UNTIL 10:29 PM. THE OPERATOR PAUSED IT AGAIN AT 10:32 PM, SHOWING A TOTAL VOLUME INFUSED (TVI) OF 118.457 ML. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORT OF OVER INFUSION OF MAGNESIUM WAS NOT ABLE TO BE IDENTIFIED FROM THE LOG ANALYSIS OR FROM DEVICE LABORATORY TESTING. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION, AND THE SEAR WAS FOUND TO BE PROPERLY CLOSING THE SAFETY CLAMP WHEN THE ADMINISTRATION SET IS REMOVED. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A0401, A1801, G02017, C07, C0601, D15, D0302 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
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.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES "2134: VERBAL ORDERS FROM MD (MEDICAL DOCTOR) TO PUT IN ORDERS FOR MAG. A 6 GRAM BOLUS WITH A 2 GRAM MAINTENANCE DOSE. REGULAR DIET AND REINSERT A FOLEY CATHETER 2145: RN (REGISTERED NURSE) STARTS THE POSTPARTUM RECOVERY PERIOD 2150: RN LEAVES THE ROOM TO GET MAGNESIUM BAGS AND ANTIBIOTIC 2200: PRIMARY RN ENTERS THE ROOM TO CHECK PATIENTS BLEEDING AND START MAGNESIUM AND ANTIBIOTICS 2203: SECOND AND THIRD RN ENTER THE ROOM TO HELP SET UP MAGNESIUM DRIP 2207: 6 GRAM BOLUS OF MAGNESIUM IS SCANNED AND STARTED. VERIFIED WITH A SECOND RN PRIOR TO STARTING 2208: RN STAYS AT BEDSIDE TO ASSESS THE PATIENT'S LUNG SOUNDS, REFLEXES AND SYMPTOMS. RN EXPLAINS TO PATIENT SIGNS AND SYMPTOMS TO REPORT 2208-2228: RN CONTINUES TO STAND AT BEDSIDE TO MONITOR PATIENT 2223: PATIENT IS VOMITING AND PRIMARY RN ASKS A SECOND RN TO BRING ZOFRAN. PATIENT COMPLAINS OF FEELING HOT 0226: SECOND RN ENTERS THE ROOM 0228: MAG PAUSED 0229: PRIMARY RN AND SECOND RN VERIFYING THE PROGRAMMING OF THE PUMP AND THE RATE OF MAGNESIUM 2231: CHARGE RN ENTERS THE ROOM 2232: FOURTH RN ENTERS THE ROOM 2234: IV FLUIDS INCREASED TO 999 2243: O2 APPLIED TO PATIENT 2250: MD NOTIFIED OF EVENTS. SAYS TO DRAW A MAGNESIUM LEVEL THEN REDRAW AGAIN IN 4 HOURS 2306: RN GETS ORDERS FROM MD TO GIVE 1 GM OF CALCIUM GLUCONATE 2306: RN CONTINUES TO STAY AT BEDSIDE TO MONITOR PATIENT ORDER WAS PLACED FOR MAGNESIUM BOLUS AT 2135. IT WAS VERIFIED BY PHARMACY AT 2140. IT WAS REMOVED FROM THE PYXIS AT 2155. PER THE REPORTS THE RN SET THE PUMP UP AT 2206 FOR A MAGNESIUM BOLUS OF 6G OVER 30 MINS FROM THE 20G/500ML BAG WITH AN INFUSION RATE OF 300ML/HR. AND VTBI OF 150ML. RATE VERIFIED BY SECOND RN AND PUMP STARTED. WHEN THE PUMP WAS STOPPED AT 2226 THE VOLUME INFUSED PER THE PUMP WAS 102.096 ML. 33-YEAR-OLD FEMALE GRAVDA 2 NOW PARA 1 DELIVERED AT 38.4 GESTATIONAL AGE. SHE DEVELOPED CHORIOAMNIONITIS DURING LABOR. THIS WAS AN IUI PREGNANCY. PT ALSO HAS A HISTORY OF HYPOTHYROIDISM AND HSV (HERPES SIMPLEX VIRUS) 1. PT WAS DIAGNOSED IMMEDIATELY POSTPARTUM WITH SEVERE PREECLAMPSIA". ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER DURING FOLLOW UP. THE CUSTOMER SPECIFIED THE EVENT TOOK PLACE AT 2226 AND THE PATIENT OUTCOME WAS "THE PATIENT REQUIRED A REVERSAL AGENT TO PREVENT HARM." AT THE TIME OF THE EVENT, THE PATIENT WAS ALSO RECEIVING 75ML/HOUR OF LACTATED RINGERS. THE CUSTOMER ALSO INDICATED THE PATIENT RECEIVED APPROXIMATELY 250 ML WITHIN A 20 MINUTE TIME PERIOD.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES: "2134: VERBAL ORDERS FROM MD (MEDICAL DOCTOR) TO PUT IN ORDERS FOR MAG. A 6 GRAM BOLUS WITH A 2 GRAM MAINTENANCE DOSE. REGULAR DIET AND REINSERT A FOLEY CATHETER. 2145: RN (REGISTERED NURSE) STARTS THE POSTPARTUM RECOVERY PERIOD. 2150: RN LEAVES THE ROOM TO GET MAGNESIUM BAGS AND ANTIBIOTIC. 2200: PRIMARY RN ENTERS THE ROOM TO CHECK PATIENTS BLEEDING AND START MAGNESIUM AND ANTIBIOTICS. 2203: SECOND AND THIRD RN ENTER THE ROOM TO HELP SET UP MAGNESIUM DRIP. 2207: 6 GRAM BOLUS OF MAGNESIUM IS SCANNED AND STARTED. VERIFIED WITH A SECOND RN PRIOR TO STARTING. 2208: RN STAYS AT BEDSIDE TO ASSESS THE PATIENT'S LUNG SOUNDS, REFLEXES AND SYMPTOMS. RN EXPLAINS TO PATIENT SIGNS AND SYMPTOMS TO REPORT. 2208-2228: RN CONTINUES TO STAND AT BEDSIDE TO MONITOR PATIENT. 2223: PATIENT IS VOMITING AND PRIMARY RN ASKS A SECOND RN TO BRING ZOFRAN. PATIENT COMPLAINS OF FEELING HOT. 0226: SECOND RN ENTERS THE ROOM. 0228: MAG PAUSED. 0229: PRIMARY RN AND SECOND RN VERIFYING THE PROGRAMMING OF THE PUMP AND THE RATE OF MAGNESIUM. 2231: CHARGE RN ENTERS THE ROOM. 2232: FOURTH RN ENTERS THE ROOM. 2234: IV FLUIDS INCREASED TO 999. 2243: O2 APPLIED TO PATIENT. 2250: MD NOTIFIED OF EVENTS. SAYS TO DRAW A MAGNESIUM LEVEL THEN REDRAW AGAIN IN 4 HOURS. 2306: RN GETS ORDERS FROM MD TO GIVE 1 GM OF CALCIUM GLUCONATE. 2306: RN CONTINUES TO STAY AT BEDSIDE TO MONITOR PATIENT ORDER WAS PLACED FOR MAGNESIUM BOLUS AT 2135. IT WAS VERIFIED BY PHARMACY AT 2140. IT WAS REMOVED FROM THE PYXIS AT 2155. PER THE REPORTS THE RN SET THE PUMP UP AT 2206 FOR A MAGNESIUM BOLUS OF 6G OVER 30 MINS FROM THE 20G/500ML BAG WITH AN INFUSION RATE OF 300ML/HR. AND VTBI OF 150ML. RATE VERIFIED BY SECOND RN AND PUMP STARTED. WHEN THE PUMP WAS STOPPED AT 2226 THE VOLUME INFUSED PER THE PUMP WAS 102.096 ML. 33-YEAR-OLD FEMALE GRAVDA 2 NOW PARA 1 DELIVERED AT 38.4 GESTATIONAL AGE. SHE DEVELOPED CHORIOAMNIONITIS DURING LABOR. THIS WAS AN IUI PREGNANCY. PT ALSO HAS A HISTORY OF HYPOTHYROIDISM AND HSV (HERPES SIMPLEX VIRUS) 1. PT WAS DIAGNOSED IMMEDIATELY POSTPARTUM WITH SEVERE PREECLAMPSIA". ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER FROM CLINICAL DUE DILIGENCE. THE CUSTOMER SPECIFIED THE EVENT TOOK PLACE AT 2226 AND THE PATIENT OUTCOME WAS "THE PATIENT REQUIRED A REVERSAL AGENT TO PREVENT HARM." AT THE TIME OF THE EVENT, THE PATIENT WAS ALSO RECEIVING 75ML/HOUR OF LACTATED RINGERS. THE CUSTOMER ALSO INDICATED THE PATIENT RECEIVED APPROXIMATELY 250 ML OF MAGNESIUM SULFATE WITHIN A 20 MINUTE TIME PERIOD.
A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES "2134: VERBAL ORDERS FROM MD (MEDICAL DOCTOR) TO PUT IN ORDERS FOR MAG. A 6 GRAM BOLUS WITH A 2 GRAM MAINTENANCE DOSE. REGULAR DIET AND REINSERT A FOLEY CATHETER. 2145: RN (REGISTERED NURSE) STARTS THE POSTPARTUM RECOVERY PERIOD. 2150: RN LEAVES THE ROOM TO GET MAGNESIUM BAGS AND ANTIBIOTIC. 2200: PRIMARY RN ENTERS THE ROOM TO CHECK PATIENTS BLEEDING AND START MAGNESIUM AND ANTIBIOTICS. 2203: SECOND AND THIRD RN ENTER THE ROOM TO HELP SET UP MAGNESIUM DRIP. 2207: 6 GRAM BOLUS OF MAGNESIUM IS SCANNED AND STARTED. VERIFIED WITH A SECOND RN PRIOR TO STARTING. 2208: RN STAYS AT BEDSIDE TO ASSESS THE PATIENT'S LUNG SOUNDS, REFLEXES AND SYMPTOMS. RN EXPLAINS TO PATIENT SIGNS AND SYMPTOMS TO REPORT. 2208-2228: RN CONTINUES TO STAND AT BEDSIDE TO MONITOR PATIENT. 2223: PATIENT IS VOMITING AND PRIMARY RN ASKS A SECOND RN TO BRING ZOFRAN. PATIENT COMPLAINS OF FEELING HOT. 0226: SECOND RN ENTERS THE ROOM. 0228: MAG PAUSED. 0229: PRIMARY RN AND SECOND RN VERIFYING THE PROGRAMMING OF THE PUMP AND THE RATE OF MAGNESIUM. 2231: CHARGE RN ENTERS THE ROOM. 2232: FOURTH RN ENTERS THE ROOM. 2234: IV FLUIDS INCREASED TO 999. 2243: O2 APPLIED TO PATIENT. 2250: MD NOTIFIED OF EVENTS. SAYS TO DRAW A MAGNESIUM LEVEL THEN REDRAW AGAIN IN 4 HOURS. 2306: RN GETS ORDERS FROM MD TO GIVE 1 GM OF CALCIUM GLUCONATE. 2306: RN CONTINUES TO STAY AT BEDSIDE TO MONITOR PATIENT ORDER WAS PLACED FOR MAGNESIUM BOLUS AT 2135. IT WAS VERIFIED BY PHARMACY AT 2140. IT WAS REMOVED FROM THE PYXIS AT 2155. PER THE REPORTS THE RN SET THE PUMP UP AT 2206 FOR A MAGNESIUM BOLUS OF 6G OVER 30 MINS FROM THE 20G/500ML BAG WITH AN INFUSION RATE OF 300ML/HR. AND VTBI OF 150ML. RATE VERIFIED BY SECOND RN AND PUMP STARTED. WHEN THE PUMP WAS STOPPED AT 2226 THE VOLUME INFUSED PER THE PUMP WAS 102.096 ML. 33-YEAR-OLD FEMALE GRAVDA 2 NOW PARA 1 DELIVERED AT 38.4 GESTATIONAL AGE. SHE DEVELOPED CHORIOAMNIONITIS DURING LABOR. THIS WAS AN IUI PREGNANCY. PT ALSO HAS A HISTORY OF HYPOTHYROIDISM AND HSV (HERPES SIMPLEX VIRUS) 1. PT WAS DIAGNOSED IMMEDIATELY POSTPARTUM WITH SEVERE PREECLAMPSIA". ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER DURING FOLLOW UP. THE CUSTOMER SPECIFIED THE EVENT TOOK PLACE AT 2226 AND THE PATIENT OUTCOME WAS "THE PATIENT REQUIRED A REVERSAL AGENT TO PREVENT HARM." AT THE TIME OF THE EVENT, THE PATIENT WAS ALSO RECEIVING 75ML/HOUR OF LACTATED RINGERS. THE CUSTOMER ALSO INDICATED THE PATIENT RECEIVED APPROXIMATELY 250 ML WITHIN A 20 MINUTE TIME PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209594 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention | 8015.| 8100(2). |