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

Model Number 2110

Device Problems Insufficient Flow or Under Infusion (2182); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: 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 patient was on a continuous pca hydromorphone drip post-surgery.The device alarmed low battery.The device was then plugged in but it would not charge.After five minutes the device wouldn't hold a charge.This resulted in patient not receiving continuous iv pain medication for 30 minutes.It was reported the patient was alert and oriented, the bedside registered nurse monitored for signs of increased pain.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: one device was returned for analysis.Visual inspection showed a damaged dso seal and bent latch lock.The tamper seal was broken.There was no evidence to review in the device's event history log.A functional test and backup battery charge were performed and the reported issue was not duplicated.The device functioned as intended.It was determined that the most probable cause was due to a depleted battery backed ram.As a result, the backup battery was charged for up to a maximum of 250 hours and standard preventive maintenance was performed.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.D3, g1, and g2 email is: (b)(4).

• 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: 17821726
• MDR Text Key: 324333657
• Report Number: 3012307300-2023-09263
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: 15019517099690
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 21-2111-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1