MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A nurse at the user facility reported that the ¿machine was behaving like it had an air lock because the blood would not move through the lines.¿ however, no actual air lock occurred.The patient was moved to another machine, re-setup with a new circuit, and then the hd therapy was continued.The treatment was able to be successfully completed without any further issues.According to the staff, the patient¿s blood was not rinsed back because it was such a small amount.The patient¿s estimated blood loss (ebl) was noted as being approximately 30cc or 1 set.No patient adverse effects occurred and no medical intervention was required as a result of this event.Following this event, the unit was pulled from service for evaluation.The biomed removed the blood pump (bp) rotor from the machine.Functional testing revealed that one of the rollers on the bp rotor was stuck.The biomed replaced the rotor wheel to resolve the issue.The unit was returned to service at the user facility with no recurrence of the event as reported.No parts are available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.Following the event, the unit was pulled from service for evaluation.The biomed removed the blood pump (bp) rotor from the machine.Functional testing revealed that one of the rollers on the bp rotor was stuck.The biomed replaced the rotor wheel to resolve the issue.The 2008t hemodialysis (hd) machine was returned to service at the user facility with no recurrence of the event as reported.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5856683
• MDR Text Key: 51507984
• Report Number: 2937457-2016-00842
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

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
• Device Model Number: 2008K
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2008
• 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