MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING PD PRODUCTS - REYNOSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 07/06/2014

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) nurse reported that a pt presented with abdominal pain, fever, and the window of the bag was hazy the morning of (b)(6) 2014.The nurse stated she does not think it's related to the cycler and it was not touch contamination.The nurse stated the pt missed one bowel movement.Medical records from the pt's treatment facility show that pt had (b)(6) that was treated with unk antibiotics.

Manufacturer Narrative

The post market clinical staff reviewed the provided medical records.Based on the medical records info and a review of the provided follow up info, it appears that on (b)(6) 2014, the pt had symptoms of peritonitis.On (b)(6) 2014, the pt's daughter brought in a bag of the pt's pd fluid to the clinic, which appeared cloudy.The pt had abdominal pain and fever.A culture of the pt's effluent pd fluid showed (b)(6).There was no further info provided in the pt's record.The pt's pd rn stated that she did not believe that the peritonitis was cycler or contamination related.This event will be reported as an mdr serious injury.

• Brand Name: PD PRODUCTS - REYNOSA
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4009125
• MDR Text Key: 4707782
• Report Number: 8030665-2014-00601
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PD SOLUTION; LIBERTY DIALYSIS
• Patient Outcome(s): Other
• Patient Age: 60 YR