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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS PCA CASSESTTE; SET, I.V, FLUID TRANSFER
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SMITHS MEDICAL ASD, INC. CADD SOLIS PCA CASSESTTE; SET, I.V, FLUID TRANSFER Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Smith's medical, the manufacturer of the cadd solis pca, is experiencing a shortage of both the cassettes used to make the pcas and the connector tubing needed to connect the infusion bags to the cadd solis pumps.In order to conserve supplies, multiple changes to help facilitate patient care however there are multiple safety implications and concerns - controlled substances pcas require lockboxes, which additional lockboxes were purchased however, (usually yellow lockboxes are used for epidural administration and clear for iv) with the limited availability of yellow boxes therefore we now have comingled clear and yellow boxes, switching to bags instead of cassettes for both iv epidural and iv pcas which can cause for mix-up (epidural intended/ordered pca be administered via iv and vice versa) -lack of yellow cassettes which nurses are used to seeing for epidurals.Quick resolution of shortage reminders to staff to remain diligent on tracing and labeling lines not rely on color of lines / cassettes.Drug shortage similar labels / packaging drug shortage.Circumstances or events have capacity to cause error.(b)(6).Submission id: (b)(4).
 
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Brand Name
CADD SOLIS PCA CASSESTTE
Type of Device
SET, I.V, FLUID TRANSFER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key13711298
MDR Text Key287118257
Report NumberMW5107972
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 01/26/2022
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/08/2022
Patient Sequence Number1
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