MAUDE Adverse Event Report: HILL-ROM SINGAPORE SYNCLARA, NON-FT SW,HC,NA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number M08575

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cyanosis (1798)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that on (b)(6) 2023, the caregiver was trained on use of the synclara device and patient therapy was initiated.Per the caregiver, one treatment was performed with the respiratory trainer and the patient cried during treatment.That same night, the caregiver performed another treatment and the patient tolerated therapy.On (b)(6) 2023, the caregiver performed a treatment and the patient¿s face and fingertips turned blue/gray in color and it took 15-20 seconds to recover after finishing the treatment.The patient was reportedly limp and not himself and returned to baseline after 5 minutes.The caregiver felt the patient may have been holding his breath and is holding therapy until she receives direction from the healthcare team.On 24oct2023, a physician order was received to discontinue synclara therapy.The patient is a 1-year-old male with a medical history of prune belly syndrome, atrial septal defect, and peripheral pulmonary hypoplasia.The synclara cough system is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.The device instructions for use include the following warnings: warning¿adult supervision is required to use the therapy on children.Warning¿close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities.If at any time during the therapy, the patient shows signs of distress, immediately remove the patient circuit from the patient and stop the therapy.Have the patient attempt to cough spontaneously and examine the patient¿s airway for mucus.If necessary, use suctioning devices as directed by the physician.In this event, the patient became cyanotic and limp and is considered potentially life threatening in the setting of the patient¿s age and existing co-morbidities, concluding a serious injury occurred.The patient was stabilized at home by the caregiver and did not require additional medical intervention.Based on the information reported, it can be reasonably concluded the reported event was possibly caused by therapy intolerance and the patient holding his breath, although this was not confirmed.There was no allegation of a device malfunction.The synclara device was discontinued by the patient¿s physician and the device is being returned to baxter.If any additional relevant information is received, the additional relevant information will be submitted in a supplemental report.

Event Description

It was reported that on (b)(6) 2023, the caregiver was trained on use of the synclara device and patient therapy was initiated.Per the caregiver, one treatment was performed with the respiratory trainer and the patient cried during treatment.That same night, the caregiver performed another treatment and the patient tolerated therapy.On (b)(6) 2023, the caregiver performed a treatment and the patient¿s face and fingertips turned blue/gray in color and it took 15-20 seconds to recover after finishing the treatment.The patient was reportedly limp and not himself and returned to baseline after 5 minutes.The caregiver felt the patient may have been holding his breath and is holding therapy until she receives direction from the healthcare team.On 24oct2023, a physician order was received to discontinue synclara therapy.The patient is a 1-year-old male with a medical history of prune belly syndrome, atrial septal defect, and peripheral pulmonary hypoplasia.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: SYNCLARA, NON-FT SW,HC,NA
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18047753
• MDR Text Key: 327073865
• Report Number: 3008145987-2023-00020
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: M08575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 YR
• Patient Sex: Male