FDA Adverse Event No answer provided Summary report: N

SPECTRUM IQ

MDR report key: 14601079 · Received June 6, 2022

Report

Report Number
14601079
Event Type
No answer provided
Date Received
June 6, 2022
Date of Event
May 24, 2022
Report Date
May 31, 2022
Manufacturer
BAXTER INTERNATIONAL INC.
Product Code
FRN
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT WAS TRANSFERRED MEDICAL ICU (MICU) @1800. PATIENT ARRIVED ON STABLE DOSE OF 25MCG/MIN LEVOPHED AND WAS SWITCHED TO MICU PRESSORS @1820. PATIENT BEGIN TO HAVE CARDIAC INSTABILITY SHORTLY AFTERWARDS. UNABLE TO OBTAIN BLOOD PRESSURE READING VIA NONINVASIVE BP CUFF. VASOPRESSIN ADDED @1830 AND EPINEPHRINE ADDED @1840. EMERGENT ARTERIAL ALINE PLACED AND LEVOPHED MAXED AT 100MCG/MIN. PATIENT BEGAN CHEMICALLY CODING. RECEIVED 3 AMPS SODIUM BICARBONATE, 1G CALCIUM CHLORIDE, 150 MG AMIODARONE, 1G MAGNESIUM, AND 2MG EPINEPHRINE PUSHES BEFORE STABILIZING ON 100 MCG/MIN LEVOPHED/ 0.04 U/MIN VASOPRESSIN/ 10MCG/MIN EPINEPHRINE. AT 1955, BAXTER PUMP ALARMED "UPSTREAM OCCLUSION" ON THE PUMP RUNNING LEVOPHED. RN NOTED THAT THE BLUE CLAMP WAS PARTIALLY OCCLUDING THE INFUSION LINE AND THAT THE LEVOPHED BAG WAS STILL COMPLETELY FULL (250ML) DESPITE PUMP DISPLAY READING OF "VOLUME TO BE INFUSED" SAYING ONLY 8ML REMAINING IN BAG. UPSTREAM OCCLUSION RESOLVED BY RN, WHICH RESULTED IN THE PATIENT'S BLOOD PRESSURE SPIKING TO 211/98 (133) ON ARTERIAL LINE. RN ABLE TO IMMEDIATELY WEAN COMPLETELY OFF EPINEPHRINE AND WEAN LEVOPHED INFUSION TO 15 MCG/MIN + 0.04U/MIN VASOPRESSIN. LEVOPHED INFUSION RAN FOR 1 HOUR AND 35 MIN AT A FAST RATE (@ 187CC/HR) WITH PARTIAL CLAMPED INFUSION LINE BEFORE EVER ALARMING AND PUMP WAS NEVER SILENCED DURING PERI-CODE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2413030 SPECTRUM IQ PUMP, INFUSION FRN BAXTER INTERNATIONAL INC.

Patients

Seq Age Sex Outcome Treatment
1 23360 DA Unknown