MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA; PUMP, INFUSION

Catalog Number 21-2111-0300-01

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown, no information has been provided to date.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.

Event Description

It was reported the device failed the accuracy test, over infusing.Patient involvement unknown.

Manufacturer Narrative

Device evaluation: one device was returned for analysis in used condition.Visual inspection showed the tamper seal was removed.Functional testing included three accuracy tests and the device was found to be within manufacturing specifications.Based on the investigation, the complaint allegation was not confirmed.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS HPCA
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17445405
• MDR Text Key: 320250514
• Report Number: 3012307300-2023-07735
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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 Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/17/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1