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 08/04/2017

Event Type  Injury  

Manufacturer Narrative

A follow up will be submitted following evaluation.

Event Description

A peritoneal dialysis patient's nurse reported that the patient had been diagnosed with peritonitis (b)(6) 2017 due to a lack of proper hand hygiene during treatment.The patient was treated in the clinic and was not initially hospitalized for the event.The patient was treated with oral antibiotic linezolid for 7 days, vancomycin intraperitoneally.On (b)(6) 2017 the patient was hospitalized due to a blocked catheter attributed to fibrin build up.The fibrin was reported to be a potential side effect of the peritonitis.The patient's catheter was cleared but patient's clearance of the infection has not been confirmed as the patient remains in a hospital setting due to an unrelated fall.

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.Although a temporal relationship exists between the liberty cycler and the reported adverse event of peritonitis, there is no documentation showing a causal relationship between the liberty cycler, the hospitalization and/or the adverse event of peritonitis.Additionally, there is no allegation against any fresenius products and the adverse event.It remains unclear if patient was utilizing any fresenius products during hospitalization.There is however a probable association between the reported peritonitis and a possible breach in aseptic technique during pd therapy given the patients organism cultured was a gram positive cocci.

Event Description

On (b)(6) 2017 during a follow-up call for an unrelated event, the peritoneal dialysis registered nurse (pdrn) reported this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2017 was hospitalized for pd catheter blockage from (b)(6) 2017 through (b)(6) 2017.During the call it was reported the patient was diagnosed with peritonitis (symptoms unknown) on (b)(6) 2017.Cultures (unknown collection date) were positive for gram positive cocci (genera unknown).The patient was subsequently treated at the outpatient clinic with oral linezolid (dosage unknown) for 7 days, and with intraperitoneal vancomycin (dosage and duration unknown).The pdrn alleges the cause of the peritonitis was due to lack of proper hand hygiene during pd therapy, and the excess fibrin was probably due to the peritonitis.Pdrn unable to confirm peritonitis is completely resolved due to patient hospitalization on (b)(6) 2017 for an unrelated event.It is unknown if the performed pd therapy while hospitalized.

• 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: 6924378
• MDR Text Key: 88828865
• Report Number: 8030665-2017-00810
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• 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: 10/06/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 100