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 Abdominal Pain (1685); Fever (1858); Peritonitis (2252)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

Although a temporal relationship exists between the liberty cycler set and the reported adverse events of cloudy peritoneal effluent fluid, abdominal pain, fever and subsequent peritonitis, there is no documentation or evidence indicating a causal relationship between the liberty cycler set and the adverse events.Additionally, there is no allegation or indication any fresenius device(s) malfunctioned or failed to perform as expected.There is however an association between the reported adverse event(s) and a breach in aseptic technique during therapy as reported by the pdrn a supplemental mdr will be submitted upon device evaluation.Mdrs 8030665-2018-00181, 8030665-2018-00182, and 8030665-2018-00183 are 3 events for the same patient due to an ongoing peritonitis event.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported the patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) presented to the clinic on (b)(6) 2017 with cloudy peritoneal effluent fluid, abdominal pain, fever and was subsequently diagnosed with peritonitis.A peritoneal effluent fluid culture was collected, however the sample could not be processed as the lab deemed the sample ¿too old.¿ the patient was treated outpatient with vancomycin (dosage, frequency, route and duration unknown) and gentamycin (dosage, frequency, route and duration unknown).The pdrn reported the cause of the peritonitis is suspected to be touch contamination, as the patient is visually impaired.The pdrn is unable to provide additional information as the patient has been discharged from home therapies to in-center hemodialysis.

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.

• 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: 7238022
• MDR Text Key: 98911121
• Report Number: 8030665-2018-00181
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

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?: 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
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/24/2018
• Supplement Dates FDA Received: 02/28/2018
• 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: LIBERTY CYCLER; PD FLUID
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR