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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.11; 80MEA

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HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.11; 80MEA Back to Search Results
Catalog Number 20709
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
The customer contact reported a pt death while the device was in use.On (b)(6) 2014 at 1930 in the post anesthesis care unit (pacu), the device was programmed to deliver hydromorphone 1 mg/ml, in the pca + continuous mode, with a 0.2 mg/hour continuous rate, a 0.2 mg pca dose, an 8 minute pt lockout, and the delivery was started.At an unspecified time during the night shift, it was reported the pt was not fully verbal and able to follow some commands.At that time, the nurse and pt's husband were reportedly not concerned about pt's post-operative status.At 0000, it was reported the nurse noted that the iv site was infiltrated and turned the device off.At an unspecified time in the morning during a routine pt check, it was reported the nurse found the pt unresponsive but breathing.At this time, a rapid response team (rrt) was called which progressed into a code blue.It was reported that the advanced cardiac life support (acls) protocol was followed during the code.No specific event details were provided.The customer contact reported the pt did not return to baseline status and was transferred to intensive care unit (icu).At unspecified times in the icu, it was reported the pt's heart rate decreased and multiple code blues were called.No specific details of resuscitative efforts were provided.After an unspecified length of time, the pt's family decided to make the pt to a do not resuscitate status (dnr) and resuscitative efforts were ceased.At 1200, it was reported that the pt expired.The customer contact reported the cause of death was cardiopulmonary arrest.After an unspecified length of time, the customer reported that the vial was removed from the device.At that time it was noted that 5 ml was missing from the vial instead of the expect 1 ml.The customer contact reported during review of the device history at the user facility it was found the device was not turned off at midnight as reported.The customer indicated that there was no device malfunction identified.During testing at the user facility, the device passed testing for delivery accuracy.No additional info was provided.
 
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.The device history was downloaded at the user facility.A review of the history indicates that on (b)(6) 2014 between 1932 and 1937, the device was powered on, totals cleared 9 mg, history cleared, bar code not read alarm, hydromorphone 1 mg/ml was confirmed, clinical care area (cca) pca - standard was set, purge, device was programmed in the pca + continuous mode, with a 0.2 mg pca dose, an 8 minute pca lockout, with a 0.2 mg/hr continuous rate, 1.8 mg 1 hour dose limit, settings were confirmed, door was locked, 2 infuser paused alarms, and infusion was started twice.Between 2135 and 0512 on (b)(6) 2014, the door was opened twice and locked once, infusion was started and there was a new day stamp.Between 0513 and 0515, cca pca - standard was set, device was programmed in the pca only mode, with a 0.2 mg pca dose, a 10 minute pca lockout, with a 0.2 mg 1 hour dose limit, settings not confirmed, set 10 minute pca lockout, with a 1 mg one hour dose limit, settings were confirmed as hydromorphone 1 mg/ml, in the pca only mode, with a 0.2 mg pca dose, a 10 minute pca lockout, with a 1 mg 1 hour dose limit, and the door was locked.Between 1138 and 1204, there was one low battery alarm, the door was opened , one check vial alarm, one check syringe alarm, and the device was powered off.A review of the history indicates the device delivered as programmed.This report represents all the info known by the reporter upon query by hospira personnel.
 
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Brand Name
LC PCA REFURB 802.11
Type of Device
80MEA
Manufacturer (Section D)
HOSPIRA COSTA RICA LTD.
zona franca global
la aurora heredia
CS 
Manufacturer (Section G)
HOSPIRA COSTA RICA LTD.
zona franca global
la aurora heredia
CS  
Manufacturer Contact
juergen schmider, md, vp
275 n field dr
bldg no. h2-1e, dept no. 097u
lake forest, IL 60045
2242125740
MDR Report Key3809676
MDR Text Key4478547
Report Number9615050-2014-03174
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/03/2014
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
Device Catalogue Number20709
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2014
Initial Date FDA Received05/02/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MANUFACTURED BY HOSPIRA; HYDROMORPHONE HYDROCHLORIDE,
Patient Outcome(s) Death;
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