MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD EXTENSON SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 0.2 MCRN FILTR

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chest Pain (1776); Pulmonary Dysfunction (2019); Swelling (2091); High Pulmonary Arterial Wedge Pressure (2480)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

Information received a smiths medical cadd extension set were leaking medication out of the filter.Medication was used for pulmonary artery hypertension and noted enough medication had leaked causing patient to have a exacerbation of symptoms related to disease and was described as vital.When symptoms of pulmonary arterial hypertension were noted to be exacerbated, treatment was restarted.Serial lot numbers given to related complaint.(b)(4).

Manufacturer Narrative

Device evaluation- six unused samples were returned for evaluation.One used sample was also returned.The device examination showed no discrepancies.The returned devices were given functional testing: the used sample was found to leak near the filter.The unused samples met with specifications.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.Four of these samples were tested; all samples were found to function as expected with no leakage.The device type is 100% inspected during manufacturing to ensure no physical damage to the device components.This device type is also sampled for leak testing at regular intervals; at shift start, at beginning of each job and every 3 hours of production.The root cause of this issue has not been definitely confirmed.The manufacturing facility has previously initiated an in-depth investigation for a previous event.No corrective actions have been implemented in response to this event.

• Brand Name: CADD EXTENSON SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane; minneapolis MN 55442
• MDR Report Key: 9281633
• MDR Text Key: 165243680
• Report Number: 3012307300-2019-05857
• 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: consumer,distributor,health p
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0.2 MCRN FILTR
• Device Catalogue Number: 21-7106-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 10/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization