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 Problems Diarrhea (1811); Peritonitis (2252)

Event Date 09/06/2017

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.Although a temporal relationship exists between the liberty cycler and the reported adverse event(s) of peritonitis and c-diff, there is no documentation showing a causal relationship between the liberty cycler, the hospitalization and/or the adverse events of peritonitis and c-diff.Additionally, there is no allegation against any fresenius products and the adverse event(s).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 patient¿s organism cultured was (b)(6).Additionally, there is a probable association between the reported c-diff and the treatment of peritonitis in pd patients.

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 clostridium difficile (c-diff) and peritonitis (symptoms unknown) on (b)(6) 2017.Peritoneal effluent fluid cultures were collected (location of collection and date unknown) and results were (b)(6) for gram (b)(6) ¿ (b)(6).The patient was subsequently treated with oral vancomycin (dose and duration unknown).Per the pdrn the patient recovered from both c-diff and peritonitis.Hospital course is unknown.It is unknown if the patient performed pd therapy while hospitalized.However, the pdrn stated the patient is continuing with pd.

• 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: 6982284
• MDR Text Key: 90393344
• Report Number: 8030665-2017-00893
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/02/2017
• 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: 49 YR
• Patient Weight: 92