MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101678D-NL

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

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.The hospital has noticed this scenario occurring for about a month with every anesthesia circuit used prior to the date of this report.(b)(4).

Event Description

It was reported that during surgical procedure anesthesia administration, the connector has been disconnecting on the anesthesia circuits.It was reported that the disconnection is occurring between the "wye piece" and the "90 degree elbow" resulting in frequent accidental disconnections of the circuit.The facility states, "this is resulting in an occupational hazard of increased anesthetic vapor exposure to providers as well as placing the patients at potential risk of hypoxia and hypoventilation." the reporter also stated that the disconnection causes a prolongation of the induction.No further adverse health outcomes have been reported.

Manufacturer Narrative

The customer reported that 21 devices contributed to 21 reported events (one device per event).The customer returned one device for evaluation.It could not be determined which occurrence the device was associated with; therefore, the evaluation of the device will be used for the medwatch.The following mfrs were submitted related to the evaluation: 3012307300-2016-00299, 3012307300-2016-00354, 3012307300-2016-00461, 3012307300-2016-00462, 3012307300-2016-00463, 3012307300-2016-00464, 3012307300-2016-00465, 3012307300-2016-00466, 3012307300-2016-00467, 3012307300-2016-00468, 3012307300-2016-00469, 3012307300-2016-00470, 3012307300-2016-00471, 3012307300-2016-00472, 3012307300-2016-00473, 3012307300-2016-00474, 3012307300-2016-00475, 3012307300-2016-00476, 3012307300-2016-00477, 3012307300-2016-00478, and 3012307300-2016-00479.One portex® pediatric disposable anesthesia breathing circuit (lot number 3205026) was returned for investigation.The device was received within its original opened package.The sample's elbow and wye were measured using a coordinate measuring machine.Each component's inner diameter and outer diameter measured within specifications.Next, a force test was performed by connecting the 90 degree elbow to a test fixture which pulls the circuit until a separation occurs.This test found the wye and 90 degree elbow to separate within the specified limits.Investigation was unable to confirm the reported issue and found that the device operated as intended.

• Brand Name: PORTEX® PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6142051
• MDR Text Key: 61342688
• Report Number: 3012307300-2016-00470
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: C37101678D-NL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other