MAUDE Adverse Event Report: CAREFUSION RESUS BAG ADULT W/PEEP 6/CS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 2K8035

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Pallor (2468); Low Oxygen Saturation (2477); Loss Of Pulse (2562)

Event Date 12/02/2013

Event Type  Death  

Event Description

Additional information on (b)(6) 2014: reached out the customer to ask about sample return and she stated that legal advised to keep sample and not return for evaluation.

Manufacturer Narrative

(b)(4).Additional information on (b)(6) 2014: reached out the customer to ask about sample return and she stated that legal advised to keep sample and not return for evaluation.(b)(4).Investigation summary: unfortunately, no sample was returned for evaluation.Four pictures were received from the customer and were visually evaluated.It was observed that the connection between reservoir bag and connector of resuscitation bag looks well assembled.One sample from the current manufacturing process was reviewed in order to duplicate the reported condition, and no detaching issues were observed.It was noted that an extra force is needed to detach the reservoir bag from the resuscitation bag.A review of the internal production records could not be performed as the lot reported in this report ((b)(4)) does not belong to carefusion mexicali lot nomenclature.The manufacturing process review did not find any issues between the reservoir bag connection.Manufacturing personnel are attaching this component as is indicated in our manufacturing procedure.The connection between threaded housing with valve and reservoir bag were dimensionally inspected and components were found within specification.In addition, a stack up analysis was made and no assembly issues were noted between these two connections.Based on the investigation, the most probable cause for the issue reported could not be determined without the sample.Current product review meets carefusion specification.In addition, even if the reservoir bag detaches from resuscitation blue bag, oxygen is still supplied to patient since tube is bonded in place and not removable.Carefusion will continue to monitor and trend this issue.

Event Description

(b)(4).Patient noted to be desaturating during resuscitation.Reservoir bag disconnected, staff noticed reservoir bag was disconnected and wasn't filling up with oxygen during resuscitation efforts.Respiratory therapist reconnected and patient was resuscitated, resulted in delay of delivery of oxygen to patient during resuscitation.After returning on vent, patient pinked up.Education to staff of the new ambu bags.Additional information received on (b)(4) 2014 from ((b)(6)): facility was been using this since (b)(6) 2013.Witnessed cardiac arrest while on telemetry/ventilator.From the start of the code the patient was noted to be pink in color, pupils equal but without a pulse.After taking the patient off of the ventilator and "bagged" per our usual routine, it was noted that the patient's head immediately started turning purple.When respiratory was questioned about the change in his color, the respiratory therapist that was bagging the patient did not note any obvious air loss from the trach nor did she have any trouble giving breaths and kept bagging the patient.At that time, the reservoir bag was not verified to be on.Our previous ambu bags did not allow for the reservoir bag to become disconnected and we were not aware that this bag had the capability for the reservoir to disconnect, so it was not looked at as a possible problem.The code lasted 15 minutes and his head remained purple the entire time when the ambu bag was used with noted worsening/darkening in the color purple by the end of the code.After cardiac resuscitation, he was placed back on the ventilator and his head immediately turned pink again.The patient only desaturated/turned purple after being taken off of the ventilator and while being bagged with this ambu bag.It was not noticed until after the code that the reservoir bag was not connected/secured.After the patient was put back on the ventilator, the ambu bag was being put back in the original bag and it was noted that the reservoir bag was not connected to the ambu bag.With these new bags, the reservoir bag is not permanently secured anymore and it only slips on with a smooth edged round fitting at the base.The patient did not regain any neurological function after the code and the family withdrew life support one week later.Cause of death on the end of life paper work was anoxic brain injury.Additional information: when asked about flow rate, customer stated the flow is always set at normal procedure 15lpm.She doesn't recall the pulse oximetry before , during or after code.

Manufacturer Narrative

(b)(4).Device evaluation anticipated but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.

• Brand Name: RESUS BAG ADULT W/PEEP 6/CS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 2160 0; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3668006
• MDR Text Key: 19022271
• Report Number: 8030673-2014-00106
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 2K8035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death