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

Catalog Number 21-7023-24

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that a cadd® administration set caused the pump to alarm "upstream occlusion".This occurred during use after the set-up of the cassette and the infusion tube, which was noted as being "very difficult".The alarm was cleared after replacing the infusion tube.No injury was reported.

Manufacturer Narrative

One cadd® cadd® administration set was returned in used condition.The sample was visually inspected at a distance of 12" to 24" under normal conditions of illumination.The join between the star tube and the pump tube was detached from the housing.No marks of solvent were found in this part of the product.No obstructions were detected in any of the joins.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode could not be duplicated.The most probable root cause is that the tubing detached activated the sensors on the pump for an occlusion alarm.

• Brand Name: CADD® ADMINISTRATION 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: 7328509
• MDR Text Key: 102037739
• Report Number: 3012307300-2018-00535
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586019821
• UDI-Public: 10610586019821
• Combination Product (y/n): N
• PMA/PMN Number: K933390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 21-7023-24
• Device Lot Number: 47X434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1