MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYS., WITH CDX

Device Problems Fluid/Blood Leak (1250); Pumping Problem (3016)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant's investigation.

Event Description

A user facility technician reported that during hemodialysis treatment a machine alarmed a single needle pump problem.The patient had to be disconnected from the machine and resume therapy on a different unit.The patient did not experience any adverse event and was able to complete treatment on the other machine.The patient may have experienced blood loss from the disconnection, but the amount is unknown.Approximately 300ml of blood can be contained in the bloodlines at any given time during treatment.

Manufacturer Narrative

The reported complaint of a single needle pump problem leading to a loss of blood is not confirmed.A complaint sample has not been received for manufacturer evaluation.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the complaint sample.The actual device was not evaluated by fresenius personnel therefore the failure mode cannot be confirmed or replicated in field testing.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): 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: 5131234
• MDR Text Key: 27780348
• Report Number: 2937457-2015-01481
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• 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: 09/23/2015

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
• Other Device ID Number: 00840861100897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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