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

Catalog Number 03-2794-0

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant indicates that the device is not available for evaluation.Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A user facility reported that a hemodialysis patient experienced a blood leak during the initiation of treatment due to the separation of the clear arterial line tubing from the top of the white twister connector.The user confirmed that the port was not broken.The patient's estimated blood loss was 250cc.There were no patient complications as a result of this event and no medical intervention was required.Follow-up information was received which confirmed that the patient was able to successfully complete their treatment with a new set up.The actual sample is not available for evaluation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed however, a records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: FRESENIUS 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.; mike allen 1331; parque industrial reynosa
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5117855
• MDR Text Key: 27312893
• Report Number: 8030665-2015-00452
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 15ER01062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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