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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS CADD VIP; PUMP, INFUISON

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SMITHS MEDICAL ASD, INC. SMITHS CADD VIP; PUMP, INFUISON Back to Search Results
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021 (incident identified by vna on (b)(6) 2021 but not reported until (b)(6) 2021) call from patient caregiver who reports pt was hooked up to abt in the hospital on friday about 430p, when the rn came on saturday to assist with first home bag change, the abt was still full.The pcg/rn do not know why, they didn't think to call in then, and just changed the bag, disposing the old one.The pump has been working without issue since, pcg was suspecting maybe a clamp was closed but we discussed if a clamp was closed the pump would have alarmed.She is advised to check the pump periodically to see that it is running with green light flashing and she will do that from now on.She denies any issue over the weekend and feels she is independent with bag change.She wanted nelc to know the patient may have missed the doses from friday into saturday.She is advised to call into triage with any issues when the issue is happening and she verbalizes understanding.Fda safety report id# (b)(4).
 
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Brand Name
SMITHS CADD VIP
Type of Device
PUMP, INFUISON
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12086749
MDR Text Key260512448
Report NumberMW5102187
Device Sequence Number2
Product Code FRN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 06/24/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
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
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