MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIU 2008K/K2 TWISTER REVERSE FLOW DEVICE

Catalog Number 03-2794-0

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant's investigation.

Event Description

A user facility reported during hemodialysis treatment, a fresenius bloodline displayed clotting.The pt was removed from the machine and the treatment was set-up using a different bloodline.There was no pt harm or adverse event.A companion sample from the same lot is being returned for eval.No further info is available.

Manufacturer Narrative

The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.A request for the product and shipping container was sent to the user facility, but no response was received.There were no companion samples available, as the entire lot has been sold and distributed.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances during the mfg process.In addition, the device history review confirmed the labeling, material, and process controls were within spec.

• Brand Name: FRESENIU 2008K/K2 TWISTER REVERSE FLOW DEVICE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346806
• MDR Text Key: 35609138
• Report Number: 8030665-2015-00619
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K01425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 15CR01010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1