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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE; SET, I.V. FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CASSETTE; SET, I.V. FLUID TRANSFER Back to Search Results
Patient Problem Headache (1880)
Event Type  malfunction  
Event Description
Cnss (b)(6), reports epoprostenol 20ng/kg/min; her only complaint was her skin was pale, no chest pain, no shortness of breath.Mix tried priming the tubing and got a high pressure alarm, she tried her back up pump and also got a high pressure alarm.I advised her to mix another cassette, which she did and was able to prime the tubing, she went to hook the tubing to the hickman and the end broke off.I advised her to go to (b)(6) hospital to get her hickman repaired, which she agreed to do.She called me later that night and this morning.She said all was going well the only issue was a headache.No further details provided.Unknown lot number.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.If yes was any medical intervention provided? n/a.Is the actual cassette available for investigation? no.Did we replace the cassette? no.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.If no, what was the patient instructed to do in able to continue their infusion? n/a.Is the infusion life-sustaining? what is the outcome of the event? resolved? ongoing? reported to (b)(6) by: health professional.Reference report: mw5148525.
 
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Brand Name
CASSETTE
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key18227780
MDR Text Key329481671
Report NumberMW5148524
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/21/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/28/2023
Patient Sequence Number1
Treatment
EPOPROSTENOL SD\/ G-VELETRI.; HICKMAN CATHETER.; PUMP CADD LEGACY.; SOD CHLORIDE (1000ML/BAG).
Patient SexFemale
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