MAUDE Adverse Event Report: CAREFUSION IVENT201 CIRCUIT EXTENSION; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number M1162025

Device Problems Tidal Volume Fluctuations (1634); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission-customer advocacy has reached out to customer to provide the sample for the investigation.Ups label was provided to the customer.At this time we just received the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

Customer stated per email: hospital contact relayed that a (b)(6) old patient was placed on the ivent with the circuit plus the extension for mri use.The patient displayed signs of dyspnea, abdominal breathing and oxygen desaturation.The therapist noticed that the tidal volume was not recording on the ventilator.The therapist believes the tidal volume was set for 130cc, with a respiratory rate of 24, and an fio2 of 40%.The patient desaturated to 90% for a brief period of time.The therapist took the patient off the ventilator and manually bagged the patient.Labored abdominal breathing noted.This improved when placed back on the vent with circuit change.The therapist tried 2 other circuits with the same result.After the mri procedure was completed, the therapist removed the extension of the first circuit and attached the circuit to the ivent and this worked without incident.The therapist also tried another ivent with the circuit plus extension and this would not register any tidal volume.The patient did not have any further complications.

Manufacturer Narrative

(b)(4) additional information was obtained from the end-user as follows.The ivent kept alarming not meeting tidal volume (and the display was 0 for exhaled volume).The tidal volume set was 130cc, i believe.I believe vt was 130cc, respiratory rate i think was 24, fio2 was 40%.Patient desaturated to 90% only for a brief period as they were immediately taken off the ventilator and manually bagged.Labored abdominal breathing noted, which was observed by both the family (who were in mri at the time) and the clinicians.A clear change in breathing while on the ivent.At least three circuits with the extensions were tried on both ivents that were available.Same issue noted on both.When the extension was removed, the exhaled volumes were noted and the patient did not appear in distress (with the abdominal breathing).We found an older circuit with the long length and put it on.This worked correctly with exhaled volumes observed and no increased work of breathing noted.The mri test proceeded without any further issues.The test was delayed by at least 1 hour with these issues.No adverse impacts were noted with the patient after the older circuit was placed.The investigation concluded the following results.Both samples sent by the end-user passed both the visual inspection and testing within our facility per procedure.As such the reported failure could not be confirmed on the samples provided.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.Initial evaluation codes and follow up result code; investigation completion date.(b)(4).

• Brand Name: IVENT201 CIRCUIT EXTENSION
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5207853
• MDR Text Key: 30896547
• Report Number: 1718887-2015-00013
• 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: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: M1162025
• Device Lot Number: 104644407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR