MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number GCTCXXXX

Device Problem Fracture (1260)

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

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer "putting patient to sleep, heard a hiss, bacterial viral filter was cracked, they replaced the circuit.No patient harm".

Manufacturer Narrative

Investigation results: one opened sample was returned from customer.During evaluation, cracking in the viral filter was noticed.Failure mode confirmed.Two years of complaints were reviewed and no trend was identified.The probable root cause of this reported issue is related to an equipment failure.During review it was found that the press guides did not have a flat surface in the pneumatic press for the corrugated tubing and caused the broken condition on the filter.To correct this issue, an otc was generated to an alignment adjustment of the press rod.Personnel in the area were notified about the failure and were re-trained on the requirements specifying the critical points on areas to inspect prior to final assembly.

• Brand Name: ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, CA 60045
• MDR Report Key: 6689168
• MDR Text Key: 79145651
• Report Number: 8030673-2017-00351
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GCTCXXXX
• Device Lot Number: 0001055147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention