MAUDE Adverse Event Report: CAREFUSION RESUS, INF W/MASK, LRG TBG, P/O, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number 2K8019

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial emdr submission- patient demographics such as age, dob, gender and weight were not provided by the customer.The sample was received and decontaminated on (b)(6) 2016.This sample is now in route to our quality engineers at our manufacturing facility who will perform the full investigation.Once the investigation is complete a follow up emdr submission will be provided.The customer is unable to provide any additional information regarding the patient¿s condition at this time.

Event Description

Customer reported via email: ¿the manometer port is broken.¿ on (b)(6) 2016, customer provided additional information stating "the resus bag was used during an actual code.No, the product was not noticed of its impairment upon removing from the bag.Once the respiratory therapist entered, she noticed the manometer valve was missing (it was in the bag).The patient did end up being intubated.So, yes, the patient continued to decline while the broken resus bag was used".Customer states sample will be sent in."once the valve was noticed, another resus bag was provided.The piece is actually "broke".The plastic is broken.The valve comes already attached to the resus bag.The patient is still intubated and had to be transferred to musc¿.

Manufacturer Narrative

(b)(4) follow up emdr-one opened sample was received and the failure mode could be confirmed, the component (b)(4) was broken.The sample component was submitted for an ir (infrared spectroscopy) scan.This scan allows us to evaluate for any other characteristic that would cause the broken condition.The results of the scan were considered acceptable and no issues were found that would have contributed to this issue from the manufacturing stand point.The device history record for the finished good lot reported was reviewed for any issues related with this customer report and no issues were found.Two years of complaints were reviewed from march 1, 2014 ¿ february 29, 2016 and no trend was observed in the past six months.Based on the investigation, it is not possible to determine a root cause, since there is no evidence that the broken piece occurred during the manufacturing process.This may have happened outside the manufacturing process.Manufacturing personnel were notified regarding this issue, no further actions will be implemented as it is considered that this happened outside of the manufacturing facility.

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: RESUS, INF W/MASK, LRG TBG, P/O, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• 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 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5391101
• MDR Text Key: 36896834
• Report Number: 8030673-2016-00150
• Device Sequence Number: 1
• Product Code: OEV
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2K8019
• Device Lot Number: 0000637758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• 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