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

Catalog Number 21-2112-0300-01

Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the flow rate was too high and constantly detecting and clearing downstream occlusion.Patient involvement unknown.

Manufacturer Narrative

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.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection found the tamper seal to be broken, and a scratched lens.There was no evidence of the reported problem in the device's event history log.To conduct functional testing three accuracy tests were performed.Upon review, the reported problem was unable to be duplicated.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• 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: 17785952
• MDR Text Key: 324254370
• Report Number: 3012307300-2023-09172
• 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: 10/31/2023

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: 21-2112-0300-01
• 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
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1