MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008; FJK

Catalog Number 03-2722-9

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2015

Event Type  Injury  

Event Description

A patient reported that on (b)(6) 2015, they lost a pint of blood in the tubing of the dialysis machine.As of (b)(6) 2015, the patient continues in-center hemodialysis therapy without any further issues.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has requested medical records and investigations are pending.A supplemental medwatch report will be submitted when medical records are received.The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past three months.An alternate sample from the same lots that were sent to the customer was received from the distribution center for investigation and no defects were noted.In addition, investigations of the device manufacturing records were conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.The batch record reviews confirmed the labeling, material, and process controls were within specification.

• Brand Name: FRESENIUS COMBISET 2008
• Type of Device: FJK
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; tamaulipas 88780
• Manufacturer Contact: tanya taft,rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4739516
• MDR Text Key: 5704962
• Report Number: 8030665-2015-00222
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other