MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number 2K8035M

Device Problem Failure to Disconnect (2541)

Patient Problem Death (1802)

Event Date 09/21/2015

Event Type  Death  

Manufacturer Narrative

(b)(4) sample evaluation summary: one open sample was received it was evaluated according to our inspection procedure and did not present any visual problems.In additional the sample was submitted for a dimensional inspection, and no problems were found.The device history record for the lot reported was evaluated for any issues related with this customer report.The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed.Two years of complaints were reviewed from december 1, 2013 - november 30, 2015 and no trend was observed.Since the issue reported cannot be confirmed (the sample does not present any anomalies) it is not possible to determine the root cause of the issue reported.No corrective action will be implemented since the failure reported was not confirmed during sample evaluation.(b)(4).

Event Description

Customer stated that the mask will not come off the elbow.When the therapist went to remove the mask to continue to ventilate the patient after intubation, the mask would not come off.A new resuscitation bag was obtained.The patient came in the emergency room with cpr being performed.The patient did regain a heart rate and was intubated but passed away shortly after intubating.Customer confirmed that the patient's death was not due to product failure."we were unsuccessful at maintaining a heart rate".

• Brand Name: RESUS,ADLT,MSK,TUBE RSV,PEEP,MANO,7' TBG
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): CAREFUSION/BD; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 5825926
• MDR Text Key: 50547160
• Report Number: 8030673-2016-00158
• Device Sequence Number: 1
• Product Code: OEV
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2K8035M
• Device Lot Number: 0000785469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Date Manufacturer Received: 09/28/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death