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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number AMN520X4F
Device Problem Partial Blockage (1065)
Patient Problems Hypoventilation (1916); No Consequences Or Impact To Patient (2199)
Event Date 06/14/2017
Event Type  Injury  
Manufacturer Narrative
Investigation results: a opened samples was received for evaluation. After a visual inspection, a thin and translucent plastic layer was observed that is occluding one of the. 380" ports from 65-20009 machine end. This connector is a component which is used as part of the finished good code of amn520x4f. We were able to observe that the this specific component was molded out of cavity #14. The failure mode was confirmed. The dhr was reviewed for the lot number reported of 0001088107, and no issues were found that could relate to this customer report. Two years of complaints were reviewed from 01jul2015 to 30jun2017 and no trend was identified related to an occlusion or functional issues of this product. The probable root cause is related to equipment failure. As failure mode on 65-20009 dual lumen connector, it was identified that the interlock core pin was broken and stuck tight inside of interlock female core from molding tooling. This failure caused the occluded condition on this component. Once the interlock core pin was broken and stuck in the interlock female core, as the machine continues with its process, the interlock went completely inside the female core. This way the gap was eliminated during the same production and no other lots were affected. Immediate corrective actions consisted of notifying quality personnel from assembly and molding. 9 different lot numbers were audited by quality personnel and no further occluded connectors were found. The production was stopped and the 5 interlock core pins from the mold tooling was repaired. Capa (b)(4) was opened to follow up on corrective and preventive actions.
 
Manufacturer Narrative
Vyaire has reached out to customer three times to provide the complaint device for further investigation. A ups label was also provided to the customer each time. Unfortunately, vyaire has not received the complaint device for evaluation or the requested additional information. If a sample or any additional information becomes available a follow up emdr will be submitted.
 
Event Description
The customer "we recently had a case at one of our campuses in which the anesthesia provider was having extreme difficulty ventilating a patient. It was discovered that the breathing circuit itself was defective and was partially blocked on the shorter expiratory limb side of the circuit that attaches to the anesthesia machine. No injury identified at this date and time".
 
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Brand NameANES CIRCUIT, ADULT, 72 IN CORR, 3L BAG
Type of DeviceCIRCUIT, 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
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd
mettawa, IL 60045
MDR Report Key6708444
MDR Text Key264543741
Report Number8030673-2017-00353
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAMN520X4F
Device Lot Number0001088107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
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 Treatment Data
Date Received: 07/12/2017 Patient Sequence Number: 1
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