MAUDE Adverse Event Report: SMITHS MEDICAL CADD

Model Number 21-7301-24

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2014

Event Type  No Answer Provided  

Event Description

When pharmacy staff started adding adrucil solution to cadd medication 50ml cassette reservoir ref# (b)(4) lot number 14x324 expiration date 2019-06.The liquid medication started leaking from under the blue anti flow tab on the cassette.Compounding with a second cassette was attempted with the same result.The other three cassettes, still on hand, with the same lot number were sequestered and a different lot numbered cassette was used to complete the compounding without incident.Previous reports of leaks were attributed to new phaseal devices being attached for safety precautions for the pt and caregivers.When those reports seemed to escalate, the cassettes were brought back for examination, but usually could not be attributed to the add-on devices or pump.One cassette was reported to be leaking form the cassette, but the origin of the actual leak could not be determined upon examination when it was returned to the pharmacy.

• Brand Name: CADD
• Type of Device: CADD
• Manufacturer (Section D): SMITHS MEDICAL; st. paul 55112
• MDR Report Key: 4080875
• MDR Text Key: 16861231
• Report Number: MW5038133
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/02/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 21-7301-24
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 14X34
• Other Device ID Number: (01) 00610586027218
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention