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

Catalog Number 21-2111-0300-01

Device Problems Excess Flow or Over-Infusion (1311); Calibration Problem (2890)

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 that the device was over dispensing and needed calibration.Patient involvement unknown.

Manufacturer Narrative

One device was received.Per visual inspection, scratches liquid crystal display (lcd) lens.No evidence to review in the even history log (ehl).Per functional testing, running three accuracy tests, the pump was found to be over delivering to the manufacturing specifications.The complaint was confirmed.The most probable root cause was over delivery from the expulsor.It was unknown what caused the problem.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Action taken was "trim expulsor".

• Brand Name: CADD-SOLIS HPCA PIB PUMP
• 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: 17785889
• MDR Text Key: 323900815
• Report Number: 3012307300-2023-09169
• Device Sequence Number: 1
• Product Code: MEA
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: 09/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1