MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

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

D4, g4, are unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.H3: device has not been returned to manufacturer.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18627222
• MDR Text Key: 334355399
• Report Number: 9617604-2024-00089
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CADD RESERVOIR; CADD TUBING; MIDAZOLAM; VERSED
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic