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

Catalog Number 03-2722-9

Device Problems Failure To Adhere Or Bond (1031); Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

The combiset bloodlines were discarded by the user facility and are not available for evaluation.A supplemental report will be submitted upon completion of the plant investigation.

Event Description

The user facility reported there was a slight tear in the tubing of the patient's bloodlines during treatment, which resulted in an estimated blood loss of 250cc.The patient was set-up with new supplies on the same machine and was able to successfully complete treatment.There were no adverse effects to the patient.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation however, a companion sample from the same lot was returned for investigation and no defects or irregularities were noted.All bonds were closely reviewed and found to be properly assembled; no abnormalities were detected during the visual inspection.The venous line was found to be acceptable with no damages.One sample was tested on a 2008t hemodialysis machine for simulated use and the sample worked as intended without any abnormalities during the testing period.No leak occurred during tested period from the tubing venous chamber.In addition, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material and process controls were within specification.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynos; reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5313345
• MDR Text Key: 34131375
• Report Number: 8030665-2015-00598
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15LR01230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Age: 53 YR
• Patient Weight: 55