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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Alarm System (1012); Air/Gas in Device (4062)
Patient Problems Diarrhea (1811); Pain (1994); Abdominal Cramps (2543)
Event Date 06/13/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device was not returned for analysis. 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 a pump's settings were set as ordered by the provider. The patient called in stating that the pump was alarming and there were air bubbles in the tubing. The patient went in to the facility where nursing confirmed settings on the pump appeared correct. This was confirmed by three nurses. The pump indicated 62. 45 ml given at continuous rate of 2. 4 ml/hour and it stated reservoir volume was 47. 3 ml. The bag in the cassette appeared empty and there was air in line. The pump was disconnected. The patient is experiencing adverse side effects, including diarrhea, abdominal cramping leading to hemorrhoid issues resulting in rectal pain/irritation for approximately 5 days.
 
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Brand NameCADD MEDICATION CASSETTE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
minneapolis, MN 55442
MDR Report Key14973642
MDR Text Key303401315
Report Number3012307300-2022-13174
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/13/2022
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

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