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Device Problem No code available
Event Date 05/07/2013
Event Type  Death  
Manufacturer Narrative

(b)(4). The medical records were provided by the user facility and reviewed by post market clinical staff and physician. The pt has a history of comorbidities of a-fib with coumadin therapy, hypertensive renal disease and peripheral vascular disease. The pt began dialysis treatment and approximately one hour into treatment he began complaining of neck pain, a headache, nausea, shortness of breath and requested to be taken to the hospital. He was administered tylenol 650 mg po, 2 liters of oxygen and 300 ml normal saline prior to being transported to the hospital. The pt was then admitted to the hospital for pneumonia and transported to a pt room. The pt had complaints of back pain and was administered lortab (unknown dose) before being transported for a ct scan. When returning from the ct scan he vomited, became unresponsive and the heart monitor showed an afib rhythm. Within minutes the pt's heart monitor showed bradycardia (40 bpm) and the code team was alerted by the attending rn. The pt was unable to be resuscitated and expired approximately twenty minutes after returning from the ct scan. Based on the medical records provided, it is unknown whether the device may have caused or contributed to the reported event. Although medical records were provided, the exact cause of death is unknown. Additionally, an autopsy report or death certificate has not been provided. Currently, the manufacturing plant investigation is still on-going. A supplemental report will be submitted when the plant investigation is complete. See related mdr #'s: 1713747-2013-99906, 8030665-2013-00366, 1713747-2013-00179, 2937457-2013-00074, 3005162618-2013-00007.

Event Description

The following was reported by the user facility to the manufacturer on (b)(6) 2013. Approximately one hour into dialysis treatment the pt experienced throat/neck and feeling ill. He was transported to the hospital and subsequently expired several hours later. On (b)(6) 2013, the manufacturer received a user facility medwatch form that reported the same event as noted above.

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Manufacturer Contact
corie vazquez
920 winter street
waltham , MA 02451
MDR Report Key3164047
Report Number3005162618-2013-00007
Device Sequence Number1
Product CodeKPO
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/10/2013
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? Yes
Type of Device Usage Invalid Data

Date Received: 06/07/2013 Patient Sequence Number: 1