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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION

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SMITHS MEDICAL ASD, INC. CADD SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problems Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Manufacturer Narrative
Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported the device under infused, yondelis 500 ml over 24 hours, 180ml remained.No patient injury reported.No additional information is available.
 
Manufacturer Narrative
Other text: h6: event methods, evaluation, and conclusion codes: updated.No product sample was received; therefore, visual and functional testing could not be performed.The investigation determined the most probable cause of the reported issue was a programming issue, but the reported issue could not be confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
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Brand Name
CADD SOLIS VIP AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16786124
MDR Text Key313741586
Report Number3012307300-2023-04362
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517126587
UDI-Public15019517126587
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2120
Device Catalogue Number21-2120-0104-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/05/2023
Initial Date FDA Received04/21/2023
Supplement Dates Manufacturer Received09/22/2023
Supplement Dates FDA Received10/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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