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

Model Number 2110

Device Problem Calibration Problem (2890)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the pump failed calibration.No patient injury was reported.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D5- operator of device is unknown.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition.There was no evidence of the reported error in the event history log.The reported problem was duplicated.The failed calibration was duplicated due to the pump not detecting cassette being latched.The investigation found that the latch/lock flex was faulty which was the cause of the reported problem.The inoperable latch/lock flex was replaced as corrective action.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD SOLIS HPCA PUMPS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; infusystem; minneapolis, MN 55442
• MDR Report Key: 15821862
• MDR Text Key: 307574545
• Report Number: 3012307300-2022-27302
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: 15019517154290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1