MAUDE Adverse Event Report: ST PAUL 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  

Manufacturer Narrative

Device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device with peeling downstream occlusion (dso) seal and scratched lens.Both tamper seals were broken.There was evidence of the error recorded in the event history log.The customer reported problem was duplicated.The pump did not pass calibration and priming.This was due to an inoperable dso sensor.For corrective action the dso sensor was replaced.The root cause of the reported issue was unknown.A manufacturing device history record review was not performed, because the device is beyond a year from its manufacture date.And there was no indication of a manufacturing defect during the investigation.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).

Event Description

It was reported, that the device was giving an error.That the bag is full, but it is empty.There was no report of patient involvement or injury.

• Brand Name: CADD SOLIS HPCA PUMPS
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17175204
• MDR Text Key: 317754801
• Report Number: 3012307300-2023-06485
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2023

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: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1