FDA Adverse Event Injury Summary report: N

SYMBIQ DUAL CHANNEL INFUSER

MDR report key: 3885849 · Received June 13, 2014

Report

Report Number
MW5036697
Event Type
Injury
Date Received
June 13, 2014
Date of Event
June 3, 2014
Manufacturer
HOSPIRA, INC.
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DOCTOR AND NURSE WERE AT PATIENT BEDSIDE AT 2014. PATIENT HAD BEEN ON MAGNESIUM SULFATE INFUSION VIA TV INFUSION PUMP. MAGNESIUM D/C AT 2019 AND THE IV PUMP CASSETTE WAS REMOVED FROM THE PUMP. PT REPORTED FEELING "HOT", SHE DEVELOPED AMS, SHORTNESS OF BREATH AND PROGRESSED TO RESPIRATORY ARREST, FOLLOWED BY CARDIOPULMONARY ARREST. CALCIUM GLUCONATE ADMINISTERED AND ACLS PROTOCOL INITIATED. RETURNED TO NORMAL SINUS RHYTHM. THE PATIENT WAS THEN INTUBATED AND WAS TRANSFERRED FROM THIS FACILITY TO A HIGHER LEVEL OF CARE FOR OB/MATERNAL ICU. THE PATIENT PRESENTED (B)(6) 2014, WITH COMPLAINTS OF INCREASED BLOOD PRESSURE AT HOME, FAINT FLOATERS, HEADACHE, RESOLVED WITH REST. THE PATIENT IS A GRAVIDA 2, PARA 1-0-0-1, EDC OF (B)(6) 2014, ESTIMATED GESTATIONAL AGE OF 35 WEEKS 2 DAYS. THE PATIENT ADMITTED WITH DIAGNOSIS OF SYMPTOMATIC PREECLAMPSIA AT 35 WEEKS AND 3 DAYS. AT THAT POINT IN TIME, BLOOD PRESSURE RANGE WAS 173-119 SYSTOLIC /112-72 DIASTOLIC. BLOOD PRESSURE APPEARED LABILE. LABORATORIES AT THAT POINT IN TIME: URIC ACID 6.5, CREATININE 0.7, PLATELETS 151, AST AND ALT NORMAL. URINE PROTEIN GREATER THAN 400. THE PATIENT UNDERWENT ELECTIVE CESAREAN SECTION ON (B)(6) 2011, AT 2:05 PM. CESAREAN SECTION WAS UNCOMPLICATED. POSTOPERATIVELY THE PATIENT'S COURSE WAS UNCOMPLICATED. MAGNESIUM SULFATE STARTED AT 2:50 PM WITH A 4 G LOADING DOSE. MAGNESIUM SULFATE 2 Q/HR WAS STARTED AT 3:15. POSTOPERATIVE SYSTOLIC BLOOD PRESSURE RANGED 140-121, DIASTOLIC 93-79. PULSE OX ON ROOM AIR 94-99.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
350381 SYMBIQ DUAL CHANNEL INFUSER SYMBIQ DUAL CHANNEL IV PUMP FRN HOSPIRA, INC. 16027
350382 SYMBIQ DUAL CHANNEL INFUSER SYMBIQ IV TUBING FPA HOSPIRA, INC. 16068 4005A5H

Patients

Seq Age Sex Outcome Treatment
1 30 YR Hospitalization| L| R IV TUBING DB1879