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

Model Number 21-7106-24

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182)

Patient Problem Dyspnea (1816)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).Related to file number: 3012307300-2019-03279.

Event Description

Information was received indicating that a smiths medical cadd extension set was leaking at the filter.It was reported that the patient woke up due to their clothes being wet.Subsequently the patient contacted a nurse who, after arriving at the patient's home, noticed the set to be leaking at the filter.It was reported that the nurse then changed the set as well as the cassette, restarted the veletri treatment and that following the change the new set was also found to be leaking.It was reported that the patient showed shortness of breath.No additional adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: returned device was received in good physical condition.During the evaluation of the device leak test performed using hydrostat vessel.A leak in the filter air vent was detected on the sample received.The customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8689319
• MDR Text Key: 147705614
• Report Number: 3012307300-2019-03402
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 11/10/2019
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention