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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD®-SOLIS AMBULATORY INFUSION PUMP SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD®-SOLIS AMBULATORY INFUSION PUMP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2120-0102-51
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Complaint, Ill-Defined (2331); Underdose (2542)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
Voluntary medwatch form #: mw5066840. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a cadd®-solis ambulatory infusion pump was in use with a home care patient for infusion of antibiotics (pip tazo). According to the reporter, the total volume to be infused was 590 ml. According to the reporter, near the end of scheduled infusion (pump reservoir volume listed that 7. 8 ml remained), the user checked the attached iv bag and 170 ml remained in the bag. It was unclear what the impact to the patient was. See mfr: 3012307300-2017-00427.
 
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Brand NameCADD®-SOLIS AMBULATORY INFUSION PUMP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
3350 granada avenue
oakdale MN 55128
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6339109
MDR Text Key67696405
Report Number3012307300-2017-00518
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2120-0102-51
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/17/2017 Patient Sequence Number: 1
Treatment
CADD ADMINISTRATION SET (CATALOG # 21-7322-24); ICU MEDICAL ANTISIPHON VALVE B6013; ICU MEDICAL FILTER 0.2 B1371
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