MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS; PUMP, INFUSION, PCA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2017

Event Type  malfunction  

Event Description

While monitoring patient on a pca infusion device it was noted that the pumps reservoir remaining volume was listed as 65.2ml during am rounds.When checked again in the evening the clinician noted the reservoir remaining volume to be at 84.2ml.Clinicians reviewed and were informed that cassette had not been changed.Pump sequestered and sent to biomedical for service and reporting.Biomedical noted initial cassette volume to be 100ml morphine/ns.Biomedical contacted pharmacy and had remaining volume in reservoir removed and measured at 40ml remaining reservoir volume.Biomedical downloaded pump event history to determine volumes infused and reservoir volume remaining estimate.Pump event history forwarded to clinical and risk team to determine if user or pumps error.Pump being sent to manufacturer for event and pump analysis.Manufacturer response for onfusion pump, pca, cadd solis (per site reporter): awaiting mfr follow-up.

• Brand Name: CADD SOLIS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6364594
• MDR Text Key: 68533146
• Report Number: 6364594
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR