MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SOLIS HPCA PIB PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Fever (1858); Unspecified Respiratory Problem (4464)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported a patient experienced a continuous gpt, pump alarms and it went 80 milliliters of fluid out of 100 to infuse.The patient had a pre-existing condition as per h&p, upper respiratory symptoms, and fever, but no history or pre-existing condition relevant to the pump malfunction.The patient had been intubated prior to arrival.A cadd pump was used to infuse continuous versed drip for sedation.The medication used was midazolam.

Manufacturer Narrative

Device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

2/1/2024.One device was received for evaluation.Visual inspection found a scratched lcd lens, lifted dso, worn uso, and bad latch lock.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the reported problem.There was no fault found.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): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18627266
• MDR Text Key: 334499986
• Report Number: 3012307300-2024-00491
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 21-2111-0300-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CADD CASSETTE; CADD TUBING; MIDAZOLAM; VERSED
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic