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

Model Number 21-2112

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Type  Injury  

Manufacturer Narrative

See mfr: 3012307300-2018-00036.

Event Description

It was reported that a patient was injured while connected to a cadd® cadd®-solis ambulatory infusion pump.The pump may have given too much medicine.The patient could have had an allergic reaction to the medicine as well.No other adverse health events were reported.

Manufacturer Narrative

One device was returned for evaluation.Visual inspection found the device in good condition.A review of the event history log did not identify any issues related to the reported complaint.Functional testing involved delivery accuracy testing and found that the accuracy was within specifications.Based on the evidence, a root cause was unable to be confirmed.No fault was found with the device.

• Brand Name: CADD® CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7173086
• MDR Text Key: 96663164
• Report Number: 3012307300-2018-00037
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: 10610586038808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21-2112
• Device Catalogue Number: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention