MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP NCPAP GENERATOR SET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number PACKAGE ASSEMBLY,INFANT FLOW,LP

Device Problems Partial Blockage (1065); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

H3: 81 other - the sample has not been returned for evaluation.Therefore, no root cause determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the 7772020lp package assembly, infant flow, lp has excessive rain discharge that forms within the exhaust limb and pools at the patient interface, significantly irritating neonatal patients and posing a serious risk of water entering the patient's airway.Furthermore, there is no information regarding patient harm.

Manufacturer Narrative

Results of investigation: vyaire medical was not able to verify the reported issue.The suspect device was not returned for evaluation.Investigation findings are derived from r&d engineering investigation report (45-r5157 v.01) of rainout performance between vyaire medical infant flow-low pressure (iflp) generator and the inspire generator.The r&d team conducted several test cases to assess, verify, and understand the different scenarios of rainout as well as assess overall performance between the two generators.The r&d team repeated the testing performed by cumh.No condensate was observed in the inspiratory line or generator in both the original cumh testing or the vyaire testing.The amount of condensate in the exhaust tubing was found to be influenced by incorrect set-up.Incorrect placement of temperature probe inside the incubator was found to increase the condensate found in the iflp exhalation tube.Also, horizontal positioning of the exhalation tubing was found to increase the condensation collection in the exhalation tubing.In all testing, there was some condensation in the exhalation tubing for both the iflp generator and the inspire product.Next, the r&d team performed further testing to determine if rainout could be further reduced without causing detrimental performance.Testing with the exhalation tube slits variously closed showed some variation in the amount of condensation; however, no configuration performed consistently better than the un-modified device.In measuring the temperature of the gas in the exhalation tubing, iflp was shown to deliver a more consistent and closer humidifier temperature setting (37°c and 44mg/l) to the patient than the inspire products.The r&d team concluded their investigation none of their findings suggest that the current device (iflp) produces more condensation in the exhaust limb than either of the previous vyaire (cah) products or the initial release of the iflp; furthermore, condensation is very heavily influenced by setup, specifically with the positioning/draping of the exhalation tubing.There was no device problem detected.The amount of condensate observed in the exhaust tubing is influenced heavily by the set-up of the iflp circuit.Following the guidance of f&p and vyaire medical may reduce the amount of condensate in the exhaust line.While there was condensate in the exhaust portion of the iflp circuit, there was no condensate in the inspiratory line or generator observed in the engineering investigation.Based on the information gathered, iflp design performs as intended with an acceptable level of condensation in the exhaust line.

• Brand Name: INFANT FLOW LP NCPAP GENERATOR SET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17905700
• MDR Text Key: 325340406
• Report Number: 8030673-2023-00353
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10190752156531
• UDI-Public: (01)10190752156531
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACKAGE ASSEMBLY,INFANT FLOW,LP
• Device Catalogue Number: 7772020LP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2024
• 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