MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 09/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The attorney alleged that the suspect device was part of a recall.However, product-specific information is not provided and as such it cannot be determined if the device was part of the recall and what z number was assigned.A supplemental report will be submitted upon completion of the plant's investigation.Additional information has been requested and will be submitted upon receipt accordingly.This is one of two device reports for this event.

Event Description

The plaintiff's attorney alleged the patient experienced peritonitis from the use of the product, approximately 1 year after starting peritoneal dialysis.The patient was admitted to the hospital after noting severe abdominal pain.The hospital noted the peritonitis was caused by pseudomonas aeruginosa in dialysate fluid.

Manufacturer Narrative

Device history record was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.Since the sample was not available for investigation, no analysis was performed and the complaint is deemed not confirmed.Further attempts to obtain complete complaint details and upon receipt will be submitted accordingly.This is one of two device reports associated with this event.Related manufacturer report numbers are 2937457-2016-00385 and 8030665-2016-00170.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa, tamaulipas, mexico 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA; erika de reynosa; parque industrial reynosa; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5564385
• MDR Text Key: 42337036
• Report Number: 8030665-2016-00170
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention