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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD-SOLIS AMBULATORY INFUSION PUMP WIRELESS; PUMP, INFUSION, PCA

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ST PAUL CADD-SOLIS AMBULATORY INFUSION PUMP WIRELESS; PUMP, INFUSION, PCA Back to Search Results
Catalog Number 21-2111-0100-51
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
D5 is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.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 that the cassette assembly was defective.No patient injury was reported.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-14436.The report was submitted in error., corrected data: corrected information provided in h10.
 
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Brand Name
CADD-SOLIS AMBULATORY INFUSION PUMP WIRELESS
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
receiving dock
minneapolis, MN 55442
MDR Report Key15154372
MDR Text Key304691875
Report Number3012307300-2022-14436
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2023
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 Catalogue Number21-2111-0100-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received08/02/2022
Supplement Dates Manufacturer Received06/20/2023
Supplement Dates FDA Received06/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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