MAUDE Adverse Event Report: TELEFLEX MEDICAL PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX

Lot Number 02G1202875

Device Problem Occlusion Within Device (1423)

Patient Problem Death (1802)

Event Date 03/26/2014

Event Type  Death  

Event Description

Complaint alleges: during a re-infusion procedure, the rns (registered nurses) said they squeezed the bags repeatedly but the blood did not seem to flow.The bags filled easily, but they had trouble getting the blood out of the bag.Additional information received: the pt was getting transfused due to acute blood loss from a gunshot wound to the chest.The pt is deceased.The medical interventions performed were: chest thoracotomy, blood transfusions, chest tube, iv fluids.

Manufacturer Narrative

The device history record has been reviewed and no issues or discrepancies were found, which could potentially relate to this complaint.No rejection report was originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.A history review was conducted for similar complaints for catalog #s-250-08, and no previous complaints were found that relate to the reported issue.Device sample received by manufacturer, but investigation is still underway at time of this report.

• Brand Name: PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX
• Type of Device: TRANSFER BAG
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo ; MX
• Manufacturer Contact: jasmine brown ; po box 12600; durham, NC 27709 ; 9193614124
• MDR Report Key: 3804468
• MDR Text Key: 4525189
• Report Number: 3004365956-2014-00163
• Device Sequence Number: 1
• Product Code: PAD
• 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 Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 02G1202875
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2014
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death