ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-27174
- Event Type
- Malfunction
- Date Received
- May 24, 2024
- Date of Event
- May 1, 2024
- Report Date
- October 8, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: REPORT SOURCE OTHER. ADDITIONAL INFORMATION: IMDRF ANNEX A, G, B, C, D 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.
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.
CORRECTION: DESCRIBE EVENT OR PROBLEM, INITIAL REPORTER ADDR 1, INITIAL REPORTER ZIP, INITIAL REPORTER FACILITY NAME, REPORT SOURCE.
THE ACTUAL DATE OF EVENT IS UNKNOWN. CORRECTION: UNIQUE IDENTIFIER (UDI) #. ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORT THAT THE PROGRAMMED INFUSIONS WERE LATE TO COMPLETE WAS NOT CONFIRMED DURING THE REVIEW OF THE LOGS OR REPLICATED DURING LABORATORY TESTING. ¿ LABORATORY TEST RESULTS PERFORMED ON THE SUSPECT DEVICES CONFIRMED THE PUMP MODULES TO BE WITHIN SPECIFICATION FOR RATE ACCURACY AND WAS OPERATING AS INTENDED. ¿ BASED ON THE REVIEW OF THE PCU (S/N (B)(6)) EVENT LOG, ON APRIL 08, 2024, AT 8:36 AM, THE PUMP MODULE ALARMED FOR SAFETY CLAMP OPEN FOR SIX (6) SECONDS. AT 8:37 AM, A ONE-AND-A-HALF-HOUR BASIC INFUSION WAS PROGRAMMED AND IMMEDIATELY PAUSED FOR AN UNKNOWN DRUG ID (SUSPECTED TO BE IP NVG-2089 100MG/ML) WITH AN ENTERED RATE OF 400ML/HR AND AN ENTERED VOLUME TO BE INFUSED (VTBI) OF 600ML. FIVE (5) MINUTES LATER THE INFUSION WAS STARTED. ¿ AT 10:12 AM, THE INFUSION COMPLETED, KEEP VEIN OPEN (KVO). ¿ AT 10:16 AM, THE PUMP MODULE WAS CHANNELED OFF WITH A PRIMARY VOLUME INFUSED OF 600.026ML. ¿ BASED ON THE REVIEW OF THE PCU (S/N (B)(6)) EVENT LOG, ON APRIL 09, 2024, AT 8:11AM, THE PUMP MODULE ALARMED FOR SAFETY CLAMP OPEN FOR SIX (6) SECONDS. AT 8:12 AM, A ONE-AND-A-HALF-HOUR BASIC INFUSION WAS PROGRAMMED AND IMMEDIATELY PAUSED FOR AN UNKNOWN DRUG ID (SUSPECTED TO BE IP NVG-2089 100MG/ML) WITH AN ENTERED RATE OF 400ML/HR AND AN ENTERED VOLUME TO BE INFUSED (VTBI) OF 600ML. TWO (2) MINUTES LATER THE INFUSION WAS STARTED. ¿ FROM 8:25 AM THROUGH 9:15 AM, THE PUMP MODULE ALARMED FOR PATIENT SIDE OCCLUSION TWENTY-THREE (23) TIMES. THE INFUSION WAS RESTARTED AFTER EACH INSTANCE. ¿ AT 9:48 AM, THE INFUSION COMPLETED, KVO, THE VTBI WAS UPDATED TO 600ML, AND THE INFUSION WAS RESTARTED. ¿ AT 10:03 AM, THE PUMP MODULE ALARMED FOR PATIENT SIDE OCCLUSION. ¿ AT 10:06 AM, THE PUMP MODULE WAS CHANNELED OFF WITH A PRIMARY VOLUME INFUSED OF 701.562ML. ¿ A REVIEW OF THE PCU AND PUMP MODULE ERROR LOGS SHOWED NO ERRORS WERE RECORDED RELATED TO THE REPORTED COMPLAINT. ¿ IT IS NOT POSSIBLE TO DETERMINE WHAT THE ACTUAL VOLUME IS WITHIN AN IV CONTAINER AT THE START AND ENDING OF AN INFUSION FROM A REVIEW OF THE PCU EVENT LOG. IT IS ALSO NOT POSSIBLE TO DETERMINE WHAT THE FLUID IS THAT IS CONTAINED WITHIN THE IV CONTAINER. THIS IS NOT A FUNCTION OF THE PCU EVENT LOG; IT ONLY CAN REFLECT THE INPUTTED INFORMATION IT RECEIVES EITHER MANUALLY OR REMOTELY WITH RESPECT TO VOLUME TO BE DELIVERED AND FLUID SELECTED. ¿ INSPECTION AND TESTING OF THE INCIDENT ADMINISTRATION SET COULD NOT BE PERFORMED SINCE THE INCIDENT ADMINISTRATION SET WAS NOT RETURNED FOR INVESTIGATION. ¿ PER THE ALARIS USER MANUAL (V12.1), UNDER INFUSION CONDITIONS CAN BE THE RESULT OF BACK PRESSURE, WETTED FILTER VENTS (WHEN VENTING IS NEEDED), INCORRECT DISPOSABLE SET INSERTION OR INCORRECT CONTAINER VOLUME ESTIMATION. NONE OF THESE POSSIBLE CAUSES COULD BE INVESTIGATED SINCE IT IS NOT POSSIBLE TO KNOW WHICH IF ANY OF THESE CONDITIONS EXISTED AT THE TIME OF THE CUSTOMER¿S EVENT. ¿ VARIATIONS OF HEAD HEIGHT, BACK PRESSURE, OR ANY COMBINATION OF THESE CAN AFFECT TIME TO ALARM FOR OCCLUSIONS AND RATE ACCURACY. FACTORS THAT CAN INFLUENCE HEAD HEIGHT AND BACK PRESSURE ARE: ADMINISTRATION SET CONFIGURATION, IV SOLUTION VISCOSITY, AND IV SOLUTION TEMPERATURE. BACK PRESSURE CAN ALSO BE AFFECTED BY TYPE OF CATHETER. ¿ THE SYSTEM SHALL EXHIBIT A RATE ACCURACY AT STEADY STATE UNDER THE FOLLOWING CONDITIONS: 0.1 TO < 1 ML/H: -8% TO 5.5% ERROR AND A 1ML/H TO 999 ML/H: ± 5% ERROR. ¿ THE DEVICES WERE IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORT THAT THE PROGRAMMED INFUSIONS WERE LATE TO COMPLETE WAS NOT DETERMINED. THE INCIDENT DEVICES WERE FULLY EVALUATED, AND NO ISSUES OR ANOMALIES WERE OBSERVED REGARDING THE REPORTED ISSUE.
IT WAS REPORTED THAT THE PUMP MODULES WERE USED FOR A STUDY, "SAME SOLUTION AND PARAMETERS", BUT THE INFUSIONS ENDED AT VARIOUS TIMES (DETAILED BELOW). THE CUSTOMER SUSPECTS "THE VISCOSITY OF THE SOLUTION" AS A POSSIBLE ROOT CAUSE BUT WOULD LIKE THE MANUFACTURER TO INVESTIGATE. 5001: START 8:30; END 10:19 (19 MINS LATE). 5003: START 8:30; END 10:18 (18 MINS LATE). 5004: START 8:43; END 10:20 (7 MINS LATE). 5005: START 8:56; END 10:35 (9 MINS LATE). 5007: START 9:22; END 11:07 (15 MINS LATE). BD HAS LEARNED ADDITIONAL INFORMATION. PER MANUFACTURER'S RECORDS, THE DEVICES REPORTED BY THE COMPLAINANT WERE SOLD-TO AND LICENSED TO A DIFFERENT FACILITY. CUSTOMER STATED THAT THEY OBTAINED THESE DEVICES VIA THIRD-PARTY COMPANY "MEDICAL EQUIPMENT DOCTOR" BETWEEN "JANUARY 2022 AND MARCH 2022". WHEN ASKED IF THESE DEVICES HAVE GONE THROUGH PREVENTIVE MAINTENANCE AND CALIBRATION PROCEDURES, CUSTOMER STATED "THEY HAVE GONE THROUGH CALIBRATION PROCEDURES ONLY." WITH REGARDS TO THE DELAYED INFUSION END-TIMES, THE CUSTOMER STATED THAT THIS WAS "A BLINDED STUDY. IP CAN BE EITHER ACTIVE OR PLACEBO WHICH WAS GIVEN TO THE SUBJECT, WHICH WE CAN'T PROVIDE. I CAN JUST GIVE YOU THE NAME OF THE IP, NVG-2089 100MG/ML." THE MANUFACTURER ASKED FOR VISCOSITY VALUE OF THE FLUID (CP OR CPS); CUSTOMER STATED "CANNOT PROVIDE VISCOSITY VALUE. THE AVERAGE DILUTED IV BAG DRUG CONCENTRATION = ABOUT 64MG/ML." THE INFUSIONS WERE REPORTEDLY PROGRAMMED "BASIC INFUSION SETTING. THE NURSES PUT VTBI (VOLUME TO BE INFUSED): 600 ML, DURATION (INFUSION TIME): 1H 30 MIN, RATE WAS CALCULATED AUTOMATICALLY 400 ML/H BY THE PUMP.". INFUSION SET WAS BD ALARIS PUMP INFUSION SET REF#: 2420-0007 WITH FILTER: LOW VOLUME 0.22-MICRON AIR ELIMINATING FILTER, ITEM#: MS 428. PER CUSTOMER, THEY USED THESE "TUBING SET FOR ALL COHORTS, BUT THE ISSUES HAPPENED ONLY FOR COHORT 5. IT MEANS THE HIGHEST DOSAGE COHORT. THERE ARE NO ISSUES DURING PUMP TEST RUN WITH SAME PUMP SETTING." THE IV CATHETER SIZE/GAUGE USED DURING THE INFUSION WERE 22G FOR ALL SUBJECTS. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE PUMP MODULES WERE USED FOR A STUDY, "SAME SOLUTION AND PARAMETERS", BUT THE INFUSIONS ENDED AT VARIOUS TIMES (DETAILED BELOW). THE CUSTOMER SUSPECTS "THE VISCOSITY OF THE SOLUTION" AS A POSSIBLE ROOT CAUSE BUT WOULD LIKE THE MANUFACTURER TO INVESTIGATE. 5001: START 8:30; END 10:19 (19 MINS LATE). 5003: START 8:30; END 10:18 (18 MINS LATE). 5004: START 8:43; END 10:20 (7 MINS LATE). 5005: START 8:56; END 10:35 (9 MINS LATE). 5007: START 9:22; END 11:07 (15 MINS LATE). BD HAS LEARNED ADDITIONAL INFORMATION. PER MANUFACTURER'S RECORDS, THE DEVICES REPORTED BY THE COMPLAINANT WERE SOLD-TO AND LICENSED TO A DIFFERENT FACILITY. CUSTOMER STATED THAT THEY OBTAINED THESE DEVICES VIA THIRD-PARTY COMPANY "MEDICAL EQUIPMENT DOCTOR" BETWEEN "JANUARY 2022 AND MARCH 2022". WHEN ASKED IF THESE DEVICES HAVE GONE THROUGH PREVENTIVE MAINTENANCE AND CALIBRATION PROCEDURES, CUSTOMER STATED "THEY HAVE GONE THROUGH CALIBRATION PROCEDURES ONLY." WITH REGARDS TO THE DELAYED INFUSION END-TIMES, THE CUSTOMER STATED THAT THIS WAS "A BLINDED STUDY. IP CAN BE EITHER ACTIVE OR PLACEBO WHICH WAS GIVEN TO THE SUBJECT, WHICH WE CAN'T PROVIDE. I CAN JUST GIVE YOU THE NAME OF THE IP, NVG-2089 100MG/ML." THE MANUFACTURER ASKED FOR VISCOSITY VALUE OF THE FLUID (CP OR CPS); CUSTOMER STATED "CANNOT PROVIDE VISCOSITY VALUE. THE AVERAGE DILUTED IV BAG DRUG CONCENTRATION = ABOUT 64MG/ML." THE INFUSIONS WERE REPORTEDLY PROGRAMMED "BASIC INFUSION SETTING. THE NURSES PUT VTBI (VOLUME TO BE INFUSED): 600 ML, DURATION (INFUSION TIME): 1H 30 MIN, RATE WAS CALCULATED AUTOMATICALLY 400 ML/H BY THE PUMP.". INFUSION SET WAS BD ALARIS PUMP INFUSION SET REF#: 2420-0007 WITH FILTER: LOW VOLUME 0.22-MICRON AIR ELIMINATING FILTER, ITEM#: MS 428. PER CUSTOMER, THEY USED THESE "TUBING SET FOR ALL COHORTS, BUT THE ISSUES HAPPENED ONLY FOR COHORT 5. IT MEANS THE HIGHEST DOSAGE COHORT. THERE ARE NO ISSUES DURING PUMP TEST RUN WITH SAME PUMP SETTING." THE IV CATHETER SIZE/GAUGE USED DURING THE INFUSION WERE 22G FOR ALL SUBJECTS. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE PUMP MODULES WERE USED FOR A STUDY, "SAME SOLUTION AND PARAMETERS", BUT THE INFUSIONS ENDED AT VARIOUS TIMES (DETAILED BELOW). THE CUSTOMER SUSPECTS "THE VISCOSITY OF THE SOLUTION" AS A POSSIBLE ROOT CAUSE BUT WOULD LIKE THE MANUFACTURER TO INVESTIGATE. 5001: START 8:30; END 10:19 (19 MINS LATE) 5003: START 8:30; END 10:18 (18 MINS LATE) 5004: START 8:43; END 10:20 (7 MINS LATE) 5005: START 8:56; END 10:35 (9 MINS LATE) 5007: START 9:22; END 11:07 (15 MINS LATE) BD HAS LEARNED ADDITIONAL INFORMATION. PER MANUFACTURER'S RECORDS, THE DEVICES REPORTED BY THE COMPLAINANT WERE SOLD-TO AND LICENSED TO A DIFFERENT FACILITY. CUSTOMER STATED THAT THEY OBTAINED THESE DEVICES VIA THIRD-PARTY COMPANY "MEDICAL EQUIPMENT DOCTOR" BETWEEN "JANUARY 2022 AND MARCH 2022". WHEN ASKED IF THESE DEVICES HAVE GONE THROUGH PREVENTIVE MAINTENANCE AND CALIBRATION PROCEDURES, CUSTOMER STATED "THEY HAVE GONE THROUGH CALIBRATION PROCEDURES ONLY." WITH REGARDS TO THE DELAYED INFUSION END-TIMES, THE CUSTOMER STATED THAT THIS WAS "A BLINDED STUDY. IP CAN BE EITHER ACTIVE OR PLACEBO WHICH WAS GIVEN TO THE SUBJECT, WHICH WE CAN'T PROVIDE. I CAN JUST GIVE YOU THE NAME OF THE IP, NVG-2089 100MG/ML." THE MANUFACTURER ASKED FOR VISCOSITY VALUE OF THE FLUID (CP OR CPS); CUSTOMER STATED "CANNOT PROVIDE VISCOSITY VALUE. THE AVERAGE DILUTED IV BAG DRUG CONCENTRATION = ABOUT 64MG/ML." THE INFUSIONS WERE REPORTEDLY PROGRAMMED "BASIC INFUSION SETTING. THE NURSES PUT VTBI (VOLUME TO BE INFUSED): 600 ML, DURATION (INFUSION TIME): 1H 30 MIN, RATE WAS CALCULATED AUTOMATICALLY 400 ML/H BY THE PUMP.". INFUSION SET WAS BD ALARIS PUMP INFUSION SET REF#: (B)(4), WITH FILTER: LOW VOLUME 0.22-MICRON AIR ELIMINATING FILTER, ITEM#: MS 428. PER CUSTOMER, THEY USED THESE "TUBING SET FOR ALL COHORTS, BUT THE ISSUES HAPPENED ONLY FOR COHORT 5. IT MEANS THE HIGHEST DOSAGE COHORT. THERE ARE NO ISSUES DURING PUMP TEST RUN WITH SAME PUMP SETTING." THE IV CATHETER SIZE/GAUGE USED DURING THE INFUSION WERE 22G FOR ALL SUBJECTS. ALTHOUGH REQUESTED, THE CUSTOMER IS UNABLE TO RETURN ANY OF THE SAMPLES SINCE THEY STILL "HAVE ONGOING STUDIES THAT WILL NEED THESE PUMPS." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE PUMP MODULES WERE USED FOR A STUDY, "SAME SOLUTION AND PARAMETERS", BUT THE INFUSIONS ENDED AT VARIOUS TIMES (DETAILED BELOW). THE CUSTOMER SUSPECTS "THE VISCOSITY OF THE SOLUTION" AS A POSSIBLE ROOT CAUSE BUT WOULD LIKE THE MANUFACTURER TO INVESTIGATE. 5001: START 8:30; END 10:19 (19 MINS LATE), 5003: START 8:30; END 10:18 (18 MINS LATE), 5004: START 8:43; END 10:20 (7 MINS LATE), 5005: START 8:56; END 10:35 (9 MINS LATE), 5007: START 9:22; END 11:07 (15 MINS LATE). BD HAS LEARNED ADDITIONAL INFORMATION. PER MANUFACTURER'S RECORDS, THE DEVICES REPORTED BY THE COMPLAINANT WERE SOLD-TO AND LICENSED TO A DIFFERENT FACILITY. CUSTOMER STATED THAT THEY OBTAINED THESE DEVICES VIA THIRD-PARTY COMPANY "MEDICAL EQUIPMENT DOCTOR" BETWEEN "JANUARY 2022 AND MARCH 2022". WHEN ASKED IF THESE DEVICES HAVE GONE THROUGH PREVENTIVE MAINTENANCE AND CALIBRATION PROCEDURES, CUSTOMER STATED "THEY HAVE GONE THROUGH CALIBRATION PROCEDURES ONLY." WITH REGARDS TO THE DELAYED INFUSION END-TIMES, THE CUSTOMER STATED THAT THIS WAS "A BLINDED STUDY. IP CAN BE EITHER ACTIVE OR PLACEBO WHICH WAS GIVEN TO THE SUBJECT, WHICH WE CAN'T PROVIDE. I CAN JUST GIVE YOU THE NAME OF THE IP, NVG-2089 100MG/ML." THE MANUFACTURER ASKED FOR VISCOSITY VALUE OF THE FLUID (CP OR CPS); CUSTOMER STATED "CANNOT PROVIDE VISCOSITY VALUE. THE AVERAGE DILUTED IV BAG DRUG CONCENTRATION = ABOUT 64MG/ML." THE INFUSIONS WERE REPORTEDLY PROGRAMMED "BASIC INFUSION SETTING. THE NURSES PUT VTBI (VOLUME TO BE INFUSED): 600 ML, DURATION (INFUSION TIME): 1H 30 MIN, RATE WAS CALCULATED AUTOMATICALLY 400 ML/H BY THE PUMP.". INFUSION SET WAS BD ALARIS PUMP INFUSION SET REF#: (B)(4) WITH FILTER: LOW VOLUME 0.22-MICRON AIR ELIMINATING FILTER, ITEM#: MS 428. PER CUSTOMER, THEY USED THESE "TUBING SET FOR ALL COHORTS, BUT THE ISSUES HAPPENED ONLY FOR COHORT 5. IT MEANS THE HIGHEST DOSAGE COHORT. THERE ARE NO ISSUES DURING PUMP TEST RUN WITH SAME PUMP SETTING." THE IV CATHETER SIZE/GAUGE USED DURING THE INFUSION WERE 22G FOR ALL SUBJECTS. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE PUMP MODULES WERE USED FOR A STUDY, "SAME SOLUTION AND PARAMETERS", BUT THE INFUSIONS ENDED AT VARIOUS TIMES (DETAILED BELOW). THE CUSTOMER SUSPECTS "THE VISCOSITY OF THE SOLUTION" AS A POSSIBLE ROOT CAUSE BUT WOULD LIKE THE MANUFACTURER TO INVESTIGATE. 5001: START 8:30; END 10:19 (19 MINS LATE). 5003: START 8:30; END 10:18 (18 MINS LATE). 5004: START 8:43; END 10:20 (7 MINS LATE). 5005: START 8:56; END 10:35 (9 MINS LATE). 5007: START 9:22; END 11:07 (15 MINS LATE). BD HAS LEARNED ADDITIONAL INFORMATION. PER MANUFACTURER'S RECORDS, THE DEVICES REPORTED BY THE COMPLAINANT WERE SOLD-TO AND LICENSED TO A DIFFERENT FACILITY. CUSTOMER STATED THAT THEY OBTAINED THESE DEVICES VIA THIRD-PARTY COMPANY "MEDICAL EQUIPMENT DOCTOR" BETWEEN "JANUARY 2022 AND MARCH 2022". WHEN ASKED IF THESE DEVICES HAVE GONE THROUGH PREVENTIVE MAINTENANCE AND CALIBRATION PROCEDURES, CUSTOMER STATED "THEY HAVE GONE THROUGH CALIBRATION PROCEDURES ONLY." WITH REGARDS TO THE DELAYED INFUSION END-TIMES, THE CUSTOMER STATED THAT THIS WAS "A BLINDED STUDY. IP CAN BE EITHER ACTIVE OR PLACEBO WHICH WAS GIVEN TO THE SUBJECT, WHICH WE CAN'T PROVIDE. I CAN JUST GIVE YOU THE NAME OF THE IP, NVG-2089 100MG/ML." THE MANUFACTURER ASKED FOR VISCOSITY VALUE OF THE FLUID (CP OR CPS); CUSTOMER STATED "CANNOT PROVIDE VISCOSITY VALUE. THE AVERAGE DILUTED IV BAG DRUG CONCENTRATION = ABOUT 64MG/ML." THE INFUSIONS WERE REPORTEDLY PROGRAMMED "BASIC INFUSION SETTING. THE NURSES PUT VTBI (VOLUME TO BE INFUSED): 600 ML, DURATION (INFUSION TIME): 1H 30 MIN, RATE WAS CALCULATED AUTOMATICALLY 400 ML/H BY THE PUMP.". INFUSION SET WAS BD ALARIS PUMP INFUSION SET REF#: 2420-0007 WITH FILTER: LOW VOLUME 0.22-MICRON AIR ELIMINATING FILTER, ITEM#: MS 428. PER CUSTOMER, THEY USED THESE "TUBING SET FOR ALL COHORTS, BUT THE ISSUES HAPPENED ONLY FOR COHORT 5. IT MEANS THE HIGHEST DOSAGE COHORT. THERE ARE NO ISSUES DURING PUMP TEST RUN WITH SAME PUMP SETTING." THE IV CATHETER SIZE/GAUGE USED DURING THE INFUSION WERE 22G FOR ALL SUBJECTS. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320343 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |