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

Catalog Number 03-2722-9

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.

Event Description

A hemodialysis inpatient user facility reported that during treatment the lines filled with air and they could not get the arterial chamber to empty of blood.The patient was reset-up on the same machine and the incident reoccurred.The patient's blood was not rinsed back both times.The estimated blood loss was 200ml's on both treatments (400 ml total).The patient was moved to a different machine and completed treatment without any ill effects or medical intervention necessary.Sample has not been returned to manufacturer.

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 3 months.A companion sample from the same lot was returned for investigation and no defects were noted.In addition, 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 COMBISET 2008
• Type of Device: FJK
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 88790 ; MX 88790
• Manufacturer Contact: dianne chin ; 920 winter st; waltham, MA 02451 ; 7816999105
• MDR Report Key: 5203989
• MDR Text Key: 30570037
• Report Number: 8030665-2015-00498
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• 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: 10/23/2015
• 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 Age: 55 YR
• Patient Weight: 106