MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET

Catalog Number 03-2795-7

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/10/2011

Event Type  Death  

Event Description

It was alleged by the attorney for the plaintiff that "as a result of exposure to granuflo." the plaintiff "suffered injuries and damages, including severe and permanent bodily injury, pain and suffering, mental anguish, and loss of capacity for the enjoyment of life", incurred "the expenses of medical and nursing care, and ultimately death." it was also alleged that decedent "experienced severe emotional distress" as a result of product use.Medical record review: (b)(4) 2011 dialysis treatment at 1645 pt found unresponsive, cpr initiated aed applied pt shocked once, the emergency medical response (emr) team was called.Cpr was continued until the emr team arrived.Pulse and respirations were regained prior to pt transport to the hospital.No further info was available in the medical records after transport.Legal file reports the pt was transported to the hospital and expired at approx 11:00pm.

Manufacturer Narrative

This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius products being used at the time of the event.Product identifiers were not provided for eval a historical record review of the production lots identified though the treatment record review has been requested however, has not been completed.A supplemental report will be submitted upon completion of the investigation.This medwatch report is associated with mdrs #1225714-2014-01235, 2937457-2013-00091, 1713747-2014-00115, 1713747-2014-99915.

• Brand Name: COMBI SET
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas CP 88 780; MX CP 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3692369
• MDR Text Key: 4303458
• Report Number: 8030665-2014-00215
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2795-7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR