MAUDE Adverse Event Report: HALYARD HEALTH BALLARD FLEX HME; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES

Model Number 150

Device Problem Split (2537)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

Halyard received a single report that referenced three different incidences, which were associated with separate units, involving one patient.This is the first of three reports.Refer to 8030647-2015-00009 for the first report.Refer to 8030647-2015-00010 for the second report.It was reported by the caregiver, "that the heat moisture exchanger looks and smells different than the previous heat moisture exchanger and has a strong plastic odor that dissipates after it is allowed to "air out" for a few hours.The plastic also seems thinner." there have been three occurrences in the last two months where the "bars" of the plastic "cage" that surround the sponge have been split or broken apart and has led to a whistling sound as you can hear the air moving through and a decrease in the peak inspiratory pressure which is steady at 38.The caregiver noted a drop to 32 which was corrected after changing out the heat moisture exchanger.The settings are set at 50/14 and there have been no adverse effects or alarms at this setting.The caregiver has used the heat moisture exchanger for a long time and only recently had issues".

• Brand Name: BALLARD FLEX HME
• Type of Device: VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 4919613
• MDR Text Key: 22456527
• Report Number: 3011270181-2015-00011
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 150
• Device Catalogue Number: 991093816
• Device Lot Number: 2015-02-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• 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: Unknown
• Patient Sequence Number: 1