MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number 490900-NL

Device Problem Device Alarm System (1012)

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

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

User facility reported that upon immediate use, the anesthesia machine gave off the leak warning.No patient injury occurred.

Manufacturer Narrative

The customer reported that eight devices contributed to eight reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported event was associated with the returned device; therefore, the evaluation of the one returned device will be used for the medwatch.The following mfr's were submitted related to the evaluation: 2183502-2016-01343, 2183502-2016-01342, 2183502-2016-01341, 2183502-2016-01340, 2183502-2016-01339, 2183502-2016-01338, 2183502-2016-01337, and 2183502-2016-01356.One portex® pediatric disposable anesthesia breathing circuit was returned for investigation.The device was received opened and without its original packaging.A review of the device history record found no non-conformities or issues during manufacturing.Visual inspection was performed at a distance of 12" to 24" and under normal conditions of illumination.Examination found no visible tears on the tube and not defects with the returned device.During functional testing, the device was leaked tested; no leaks were observed.An audit was performed on (b)(4) device samples from the product floor inventory.The devices are manufactured with the same process procedures as the reported device.The devices were visually inspected and leak tested.No fault was the device samples during the audit.Investigation was unable to confirm the reported issue and found that the returned device functioned as intended.

• Brand Name: PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5771206
• MDR Text Key: 48812899
• Report Number: 2183502-2016-01338
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E573446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 490900-NL
• Device Lot Number: 3103148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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