MAUDE Adverse Event Report: FRESENIUS MED CARE FRESENIUS COMBISET 2008

Model Number CUSTOM COMBISET 2008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 05/11/2014

Event Type  Injury  

Event Description

It was reported that a pt coded during treatment at the hosp in the in-pt acute unit.No other info regarding this event is available at the time of this report.

Manufacturer Narrative

A sys level investigation has been opened to evaluate whether or not any devices in use caused, contributed or were a factor in this event.Med records have been requested for this event.Based on the info received it is undetermined whether or not any of the devices caused or contributed to this event.A supplemental report will be submitted upon completion of the post market surveillance clinical staff's assessment of the reported info and the plant's investigation.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MED CARE; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3960070
• MDR Text Key: 4556729
• Report Number: 8030665-2014-00553
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CUSTOM COMBISET 2008
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening