MAUDE Adverse Event Report: S.L.R. KM7, AUTOPISTA JOAQUIN BALAGUER TUBING, INSUFFLATION W/ .3 MIC FILT/ STRYKER ADA; INSUFFLATION TUBING, TBING W/ FILTER

Catalog Number 28-0211

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2012

Event Type  malfunction  

Event Description

Customer reported an alarm that indicated there was a leak in the line.When the customer was contacted for additional information, it was reported that the "tube was obstructed at the filter".

Manufacturer Narrative

This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides information which changes the content of this report.The original root cause was determined to be migration of the plasticizer into the filter housing.It was determined to change the filter housing.It was determined to change the filter material to a polycarbonate material which is stronger, higher impact, and more chemical resistant.It is also less affected by temperature.

• Brand Name: TUBING, INSUFFLATION W/ .3 MIC FILT/ STRYKER ADA
• Type of Device: INSUFFLATION TUBING, TBING W/ FILTER
• Manufacturer (Section D): S.L.R. KM7, AUTOPISTA JOAQUIN BALAGUER; pisano free zone, bldg. 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 4759440
• MDR Text Key: 17589599
• Report Number: 3004605321-2015-00007
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-0211
• Device Lot Number: 25962556
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2012
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2012
• Event Location: Hospital
• Date Manufacturer Received: 02/16/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2113-2013
• Patient Sequence Number: 1