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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 Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Spontaneous.Patient woke up to her pump alarming.She is not sure how long it was going off.Pump had no disposable clamp tubing error.Patient tried other pump.Other pump did not work, but it did not give her an error code.Told patient, since both pumps are not working, she will need to try a new cassette.Patient tried new cassette and pump is infusing with no further issues.Patient is premix, lot number of malfunctioning cassette is not known.No other info known.Prescriber has not been notified.Nursing is not needed.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? no; pt had backup cassette to use.Did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt 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.Patient woke up to her pump alarming.She is not sure how long it was going off.Pump had no disposable clamp tubing error.Patient tried other pump.Other pump did not work, but it did not give her an error code.Told patient, since both pumps are not working, she will need to try a new cassette.Patient tried new cassette and pump is infusing with no further issues.Patient is premix, lot number of malfunctioning cassette is not known.No other info known.Prescriber has not been notified.Nursing is not needed.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? no; pt had backup cassette to use.Did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt 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.
 
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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 Key13562562
MDR Text Key285988254
Report NumberMW5107578
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 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient SexFemale
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