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U.S. Department of Health and Human Services

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

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CAREFUSION RESUS, INF W/MASK, LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
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).
 
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Brand NameRESUS, INF W/MASK, LRG TBG, P/O, 6/CS
Type of DeviceCARDIOPULMONARY 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 Key5391101
MDR Text Key36896834
Report Number8030673-2016-00150
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received01/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8019
Device Lot Number0000637758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2016
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 Unkown

Patient Treatment Data
Date Received: 01/26/2016 Patient Sequence Number: 1
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