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

Model Number 2120

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problems Fatigue (1849); Nausea (1970)

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

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 on (b)(6) 2023 that for approximately 24 hours, patient had received 8mg/hr instead of 0.8mg/hr.Patient was still speaking but nauseated, weak and unable to transfer.Rn stated double check was completed, and was concerned the pump malfunctioned, as there was previous issue.Cassette volume was 50ml when put on and reservoir volume was 15ml, meaning patient received 175mg of hydromorphone instead of prescribed 19.2mg/24hrs.10 times prescribed dose, which could have resulted in death.Np reduced dose to 1mg/hr and 1mg q30min prn, and requested additional nursing visit to reassess patient in several hours, and ensure pain was controlled, and suffer no further ill effects.No patient injury.

Manufacturer Narrative

Other text: one device was received for evaluation.Visual inspection found the downstream occlusion seal had an air bubble, and a scratched lens.The device's event history log was reviewed for evidence of the problem, nothing was found.Three accuracy tests were performed.Upon review, the reported problem was not able to be duplicated.A 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 VIP AMBULATORY INFUSION PUMP
• 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: 16794955
• MDR Text Key: 313816850
• Report Number: 3012307300-2023-04425
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586042829
• UDI-Public: 10610586042829
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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: 2120
• Device Catalogue Number: 21-2120-0102-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1