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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL CADD(R) SOLISAMBULATORY INFUSION KIT; PUMP, INFUSION PCA

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SMITHS MEDICAL CADD(R) SOLISAMBULATORY INFUSION KIT; PUMP, INFUSION PCA Back to Search Results
Model Number 21-2101
Device Problem Device Operational Issue (2914)
Patient Problem Overdose (1988)
Event Type  Injury  
Manufacturer Narrative
The user facility has not returned the device to the manfuacturer for evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the investigation results.
 
Event Description
Per voluntary mdr (mw5043388), the user facility reported that the listed pump was in use with a patient sometime between (b)(6) 2015 and (b)(6) 2015 when the patient was overinfused with pain medication.The medication was reportedly 5x morphine or 10x hydromorphone.The cause of the overinfusion was reportedly due to the nurse having difficulty reading the pump's menu.In this case, the nurse failed to changed the medication concentration on the pump when changing pump cassette.The reporter explained that the user's eye is not drawn to the medication concentration selection located on the far right of the pump menu.
 
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Brand Name
CADD(R) SOLISAMBULATORY INFUSION KIT
Type of Device
PUMP, INFUSION PCA
Manufacturer (Section D)
SMITHS MEDICAL
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
6516287604
MDR Report Key5036178
MDR Text Key24346054
Report Number2183502-2015-00612
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
PMA/PMN Number
K072144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Report Date 08/27/2015
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 Nurse
Device Model Number21-2101
Device Catalogue Number21-2101-51
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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