MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS PD IQCARD CYCLER

Model Number LIB

Device Problem Invalid Sensing (2293)

Patient Problem Peritonitis (2252)

Event Date 07/03/2012

Event Type  Injury  

Event Description

The patient/user of the fmc dialysis device called tech support because she encountered an alarm that advised her to power off and call service.She was unable to get the alarm type, but she did say it was red.During the call, she mentioned that she was in the hosp for peritonitis.

Manufacturer Narrative

The actual device was not returned for eval and therefore, the reported event could not be confirmed or replicated.During a follow up phone call, the patient's peritoneal dialysis nurse states that the peritonitis was caused by touch contamination and not the use of the newton cycler.The fmc pharmacovigilance physician concludes peritonitis is a known serious complication of peritoneal dialysis and ther is no reported device malfunction.This is a retrospective mdr being submitted by fresenius med care as a remediation action committed to fda regarding all potential adverse events received between 21 march 2011 and 11 march 2013.

• Brand Name: FRESENIUS PD IQCARD CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): WALNUT CREEK PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 84520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4044154
• MDR Text Key: 4902754
• Report Number: 2937457-2014-02145
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K002892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 07/03/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 36 YR
• Patient Weight: 38