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

Catalog Number C45101796D-NL

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

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

It was reported that the during use of a disposable portex® anesthesia breathing circuit, the co2 port broke while turning the heat and moisture exchanger (hme).According to the reporter, the event occurred in the operating room while the device was connected to the patient.The hme was replaced.No patient injury occurred.

Manufacturer Narrative

No product was returned.Instead a picture was sent.From the picture, it can be observed a portex 120-1500ml foam hme from pn 9064/711 with the gas monitoring port broke.The customer's reported problem was "the or was using one of the disposable anesthesia breathing circuits and the co2 port broke while turning the hme".No testing could be performed because no samples were provided for evaluation.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.The packaging operations were reviewed and considered adequate and correct.During verification, 32 assemblies were reviewed in order to verify that hme assemblies are free of damage such as broken parts.None of the 32 samples had any defects.The most probable root cause was inadequate visual inspection to detect damaged hme assembly.

• Brand Name: PORTEX® ANESTHESIA BREATHING CIRCUIT
• 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. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6341343
• MDR Text Key: 67827419
• Report Number: 3012307300-2017-00496
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 15019517069990
• UDI-Public: 15019517069990
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101796D-NL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2018
• 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