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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, I.V. FLUID TRANSFER Back to Search Results
Device Problems Break (1069); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unsolicited communication from premix remodulin pt reporting 1 cassette arrived from coram "busted" and unable to be attached to pump.Advised pt she may need to use emergency vial for mix.Pt states she is aware of how to mix and has done it in the past.Reports 1 cassette, (a different cassette than the "busted" cassette) this week also reported an error of "no disposable, damp tubing.Pt tried cassette on both pumps, checked for kinked tubing, and had to change to another cassette.2 cassettes are available for inspection.Advised to empty contents into a zip lock bag and throw into regular trash.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Lot numbers for both cassettes: unknown.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key15515677
MDR Text Key301109700
Report NumberMW5112342
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 09/12/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/29/2022
Patient Sequence Number1
Treatment
PUMP; TUBING
Patient SexFemale
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