MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINSTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7359-24

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that a smiths medical cadd administration set 138 ml did not infuse at all full bag after 46 hours.The doctor instructed the patient receive a make-up infusion on (b)(6) 2019.The infusion was life sustaining and there were no reported adverse events.See mdr 3012307300-2019-04948 for the report on the pump.

• Brand Name: CADD ADMINSTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9098438
• MDR Text Key: 159370926
• Report Number: 3012307300-2019-04949
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: 10610586027406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7359-24
• Device Lot Number: 3808600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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
• Patient Age: 48 YR
• Patient Weight: 95