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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX PE SAHARA ATS BAG LF; AUTOTRANSFUSION BAGS
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TELEFLEX PE SAHARA ATS BAG LF; AUTOTRANSFUSION BAGS Back to Search Results
Catalog Number S-100-08LF
Device Problem No Flow (2991)
Patient Problem Blood Loss (2597)
Event Date 05/07/2014
Event Type  malfunction  
Event Description
Alleged issue: ats bag s-100-08lf with chest drain s-1100-08lf was used on a patient with a gunshot wound.The first ats bag filled to 1100 ml in less than 10 minutes and was detached from the drain.A second ats bag was attached which filled to 700 ml.The first bag was spiked with their tubing through the ats port but the blood would not flow through the tubing.Blood was administered to the patient by another process.The patient's condition was reported as critical.
 
Manufacturer Narrative
No sample is available for the manufacturer to evaluate at the time of this report.Manufacturer will continue to monitor and trend related complaints.
 
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Brand Name
PE SAHARA ATS BAG LF
Type of Device
AUTOTRANSFUSION BAGS
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer Contact
effie jefferson, rn
p.o. box 12600
durham, NC 27709
9194332672
MDR Report Key3905087
MDR Text Key20660555
Report Number3004365956-2014-00195
Device Sequence Number1
Product Code CAC
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 Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberS-100-08LF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/07/2014
Initial Date FDA Received05/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
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