MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.There is no documentation in the complaint file supporting an association between the liberty cycler or the cycler set and the event of acinetobacter baumannii peritonitis.The pd nurse attributed the infection to a breach in technique.Additionally, there is no allegation against fresenius products in relation to this event.

Event Description

A peritoneal dialysis patient reported he was on antibiotics for an undisclosed reason.During follow up it was reported by the peritoneal (pd) nurse that this end stage renal disease (esrd) patient on continuous cyclic peritoneal dialysis (ccpd) therapy for renal replacement therapy (rrt) had an episode of acinetobacter baumannii peritonitis.Reportedly, on (b)(6) 2017 the patient went to the clinic with cloudy effluent and abdominal pain.A culture from an unknown source was taken (results unknown) and the patient was prescribed vancomycin and ceftazidime (route, dose and duration unknown).The culture results received (b)(6) 2017 were positive for acinetobacter baumannii which was attributed to a breach in technique.The patient continued ceftazidime and has been cleared of infection and considered recovered.The patient was not hospitalized for the event.No sample was made available.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7042501
• MDR Text Key: 92366796
• Report Number: 8030665-2017-00990
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/27/2017
• 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: DELFLEX PD FLUID; LIBERTY CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 74