MAUDE Adverse Event Report: CAREFUSION CIRCUIT ANESTHESIA NEONATAL HCH FILTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number 1552017

Device Problems Disconnection (1171); Protective Measures Problem (3015); Ventilation Problem in Device Environment (3027)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission.It has been confirmed the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with device.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

The circuits come apart from the wye very easy.Reconnection needs to be made a minimum of one time per surgery case.Customer states "no patient has been harmed by this occurrence.However multiple instances of the patient not being ventilated have occurred due to drape placement, and inability to see disconnection when it occurs.Anesthesia machines did alarm appropriately, notifying the anesthesia provider of the disconnect.This has resulted in the need to rapidly ventilate the patient to bring the spo2 back to a normal range.We do not consider this to have caused "harm" to the patient as it did not affect the patient the long term.If the anesthesia provider and rn in the room felt as the patient was caused harm and internal incident report would have been created and sent to our risk management department and possibly we would have reported our concerns to the fda ourselves.All the times that manual or rapid ventilation occurred; the patient did not drop below 70% spo2 and was able to be brought to normal spo2 range within a very short time frame.I was not advised by any crna or md that any further steps were needed to be taken other than letting carefusion know that they were not satisfied with the function/build of the neonatal circuit and that they would like to have this issue fixed".

Manufacturer Narrative

(b)(4) probable root cause conclusion states not confirmed the reported failure could not be duplicated.The end user sent in 20 sets of samples.On all 20 sets part #073-007043 is connected into part #073-007042g for both the clue and the clear lines.None of the sets sent by the end user exhibit a disconnection as depicted with the photograph that was also provided by the end user.It can also be stated that with some force both the blue and the clear lines can be disconnected from part #073-007042g.These parts are assembled by hand and: (1) pull tested as per (b)(4), (2) functionally tested as per (b)(4), and (3) pressure tested as per (b)(4).Also the fittings are inspected as per (b)(4): ¿no loose or mis-inserted fittings allowed.¿ the end user¿s processes should be evaluated.As per the ifu, the end user is to check the connections prior to use.Based on the statements provided by the end user: it does not sound like their connections are being checked and maintained during use.As per the ifu 100% of the time before use and testing: ¿ensure that all connections are tight and have not loosened during transit.There are many scenarios that could lead to the parts becoming disconnected or loosened prior to use.For instance, as per the ifu: during the transportation process.This product is also not sterile.Due to these facts, the first instruction within the ifu is to make sure 110% of the time the parts are connected properly prior to use or testing.Due to the severity of the issue (mdr), and due to the fact that this is the first report by an end user for this failure: a review from 2013-2015 was conducted into all of the raw material parts used within the circuit anesthesia neonatal hch filter assemblies.From 2015-2015, there are no drs on record for any subcomponents.There are also no other customer complaints of a similar nature during 2015 for part #1552017.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: CIRCUIT ANESTHESIA NEONATAL HCH FILTER
• 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: 5167691
• MDR Text Key: 29306358
• Report Number: 1718887-2015-00010
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1552017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention