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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4152726
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2021
Event Type  malfunction  
Event Description
Spontaneous; call received from patient stating that he is trying to get the air out after mixing the cassette.Instead of air coming out, the medication is coming out from the cassette to the syringe.Reached out to richard, cnss and advised if patient has the cassette is placed correctly in the cup (diagnostically) and blue tap should face upwards.Patient said it is placed correctly and it is the first time with this issue.The cassette's lot#4152726.Advised patient to prepare a new mix.Patient said he has enough medication and supplies, and will call pharmacy on monday to place the orders.Did not occur while in use.No clinical injury.Advised patient to keep the faulty cassette.Patient will call pharmacy to place more cassettes.Did the reported product fault occur while in use with the pt? no; 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? pt has enough, he will, pharmacy to place more today.Did the pt have add'l cassettes they were able to switch to? yes.Reported to (b)(6) by pt/(b)(6).
 
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Brand Name
CASSETTE MEDI RESERVOIR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key12681781
MDR Text Key278160921
Report NumberMW5104854
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/17/2021
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 Lay User/Patient
Device Lot Number4152726
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age64 YR
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