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 Blood Loss (2597)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

A biomedical technician reported that user discovered the saline bag was too full while a patient was being dialyzed.The nurse reported that the patient was brought in for dialysis in bed.The patient was not aware of the surroundings.The machine was taken out of recirculation mode.Before the patient was connected the saline bag was double clamped.The patient was hooked up for dialysis and was no treatment for 30 minutes before the nurse noted that the saline bag was more full than it should be.The nurse called the biomed technician and was informed that the patient should be disconnected.The nurse stopped treatment and disconnected the patient without using the saline bag to flush the blood line.The nurse did not experience any adverse event and was not exposed to the saline.No treatment was necessary for the minor blood loss.The patient was taken to another hemodialysis machine to finish treatment and the affected machine was taken out of service.On site biomed technician replaced valve 30.Since the repair the system was placed back in use without further issue.

Manufacturer Narrative

Investigation 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 and suspected dialysate intrusion 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, CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3915463
• MDR Text Key: 15366133
• Report Number: 2937457-2014-00286
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

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?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• 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)
• Patient Age: 65 YR
• Patient Weight: 65