Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Spontaneous.Pt's husband reports cadd legacy pump serial number (b)(4) maintenance due 01/21/2023 alarmed for no disposable.Since change was due anyway, they just switched new cassette to new pump prior to contacting pharmacy; unable to troubleshoot issue.Advised no disposable alarm is usually cassette issue, not pump.Advised they retry alarming pump with next cassette change and if issue persists to contact pharmacy to advise and request replacement pump.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? yes; did we replace device? no; did the patient have a backup device they were able to switch to? yes; was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
 
Event Description
Spontaneous.Pt's husband reports cadd legacy pump serial number (b)(4) maintenance due 01/21/2023 alarmed for no disposable.Since change was due anyway, they just switched new cassette to new pump prior to contacting pharmacy; unable to troubleshoot issue.Advised no disposable alarm is usually cassette issue, not pump.Advised they retry alarming pump with next cassette change and if issue persists to contact pharmacy to advise and request replacement pump.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? yes; did we replace device? no; did the patient have a backup device they were able to switch to? yes; was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key13500384
MDR Text Key285558599
Report NumberMW5107336
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date01/21/2023
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexFemale
-
-