MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Catalog Number 050-87216

Device Problem Fluid/Blood Leak (1250)

Patient Problems Uremia (2188); Peritonitis (2252)

Event Date 01/16/2014

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) pt reported that following treatment she opened the door of the cycler and discovered fluid coming from the bottom of the pump area around the cassette.She was advised to contact her pd nurse and discontinue using the cycler.The pt called her nurse and was advised to come to the clinic for evaluation following the leak.The pt refused when asked to come in for pd cultures and start prophylactic antibiotics.On (b)(6) 2014 the pt came into the clinic for a scheduled visit.The nurse reported she was very confused, pale, and her temperature was elevated.Pt denied abdominal pain.When the nurse tried a manual drain her pd effluent was cloudy and only drained estimated 50-100 ml.Pt was sent to hospital for evaluation for peritonitis and uremia.Pt was hospitalized for peritonitis and uremia.Antibiotics vancomycin and ceftazidime were prescribed.Pt received 2 units of blood for persistent anemia due to end stage renal disease (esrd).Pt continued pd treatment in the hospital.The pt was released from the hospital to home on (b)(6) 2014.

Manufacturer Narrative

This report is associated with mdr xx.The device has not been returned for evaluation at this time.A supplemental report will be submitted upon completion of the plant's investigation.Medical records were provided and have been reviewed by post market clinical staff and physician.Pt is a (b)(6) year old female pt with esrd on pd with history of failed kidney transplant.Pt has a history of non-compliance with pd treatment.Chief complaints in the emergency room (er) were lethargy and low-grade fever 99.5 f.Er noted possible peritonitis.The pt was admitted to the medical floor to check pd fluid for cell count, culture and sensitivity including checking blood cultures.Iv antibiotics ceftazidime and vancomycin 1 dose were given in emergency department as well as 2 units of blood.Pd cultures were positive for inflammation.This was assessed as complicated peritonitis requiring hospitalization.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal #326; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3669568
• MDR Text Key: 4344520
• Report Number: 8030665-2014-00155
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Type of Report: Initial
• Report Date: 01/17/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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: LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 82