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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA LIFECARE PCA

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HOSPIRA LIFECARE PCA Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 02/28/2014
Event Type  Death  
Event Description
Hospira pca pump was placed on pt post-op surgery for small bowel obstruction, in pacu, at approx 6:30pm.Continuous dose of dilaudid infused per orders until approx 0515am on (b)(6) 2014, when pump was turned off.Pt did not receive bolus doses per the hospira pump report.At 0630 (b)(6) 2014, pt was found unresponsive.Rapid response team and physician responded.Narcan was given.Pt was transferred to icu where her heart rate slowed and she was coded.She would regain a normal rate then the heart rate would again slow down to extremely low rates and require resuscitation.This continued several times throughout the morning.At approx 1:30 pm, the pt did not respond to resuscitate efforts and died.Pharmacy reviewed the pump settings per the pump report and confirmed that it was programmed correctly.Dose of medication used coincided with ordered amount plus amount for priming the tubing initially.
 
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Brand Name
LIFECARE PCA
Type of Device
LIFECARE PCA
Manufacturer (Section D)
HOSPIRA
MDR Report Key3777494
MDR Text Key4432742
Report NumberMW5035800
Device Sequence Number1
Product Code MEA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/24/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DILAUDID 1MG/ML AT 0.2MG/HR
Patient Outcome(s) Death;
Patient Age67 YR
Patient Weight84
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