MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS

Device Problems Mechanical Problem (1384); Reflux within Device (1522); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

A user facility reported the saline bag back filled during recirculation.The device was removed from service.There was no patient involvement.A fresenius medical care technician replaced the air separator and flow relief pressure regulator.Since the repair the system was placed back in use without further issue.

Manufacturer Narrative

Investigations findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been no adverse events associated with the reported issue.The report is being investigated by the manufacturer via a capa.The investigation is pending; a supplemental mdr will be filed at the completion of the investigation.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.,; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3755466
• MDR Text Key: 16803336
• Report Number: 2937457-2014-00216
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK SALINE (DISCARDED - NOT USED)