MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87212

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problems Abdominal Pain (1685); Peritonitis (2252); No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.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.

Event Description

A peritoneal dialysis (pd) patient reported that the cycler alarmed for air detected in the cassette during drain 2 of 5.The patient had been advised to cancel the treatment and re-setup the cycler with all new supplies.As the patient was removing the cassette from the cycler the patient discovered fluid leaking out of the cassette and noted that the back of the cassette was torn.Additional information received from the patient confirmed that the patient had not experienced any adverse event.The patient visited the dialysis clinic the following day and received prophylactic antibiotic treatment.The set was not made available for evaluation.

Manufacturer Narrative

Patient codes have been updated for additional information received for this reported event.Clinical review of all information currently available concluded that there was no information provided that indicated a causal relationship between the peritoneal dialysis and use of fresenius products and the peritonitis.The most common cause of peritonitis is a breach in technique or biofilm on the peritoneal dialysis catheter.

Event Description

Subsequent information received during follow-up with the patient¿s pd nurse confirmed that the patient was treated with the antibiotic vancomycin 2 grams and gentamicin 80 gram via the intraperitoneal route.The patient subsequently complained on (b)(6) 2017 or (b)(6) 2017 of abdominal pain and cloudy effluent.The patient presented to the clinic on (b)(6) 2017 to have the peritoneal dialysis fluid cultured.The culture results were negative for growth after five days however the cell count was 8,137 and the poly-morphonuclear cells 83%.The patient was diagnosed with peritonitis and was treated with vancomycin 2 grams and gentamicin 80 grams via intraperitoneal route again.The pd nurse stated that the peritonitis was related to the fluid leak.The pd nurse reported that the patient was not hospitalized, is now recovering and adequately dialyzing.

Manufacturer Narrative

Additional information received for this reported event.Corrected lot number: 16hr08009 conclusion: there is a probable temporal association between the patient experiencing a fluid leak during ccpd treatment on (b)(6) 2017, abdominal pain, cloudy effluent fluid and the subsequent development of confirmed peritonitis and the fresenius products exists.Additionally a probable causal relationship exists between the fluid leak, torn cassette and the patient¿s development of abdominal pain cloudy effluent and subsequent peritonitis requiring outpatient antibiotic therapy.The patient received a replacement liberty cycler.The etiology of peritonitis is likely related to a breach in sterility during ccpd therapy when the patient experienced this fluid leak with fresenius products.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017 it was reported the peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy reported having fluid leaking out of the cassette and noted the back of the cassette torn during peritoneal dialysis (pd) treatment.On (b)(6) 2017, the patient followed up at the pd clinic to receive prophylactic antibiotic therapy.During a follow up call with the patient¿s pd nurse, it was confirmed that the patient was seen in clinic on (b)(6) 2017 for an episode of peritonitis related to the fluid leak event.The patient did not complete the ccpd therapy until liberty cycler replaced.The patient was reportedly treated (prophylactically) with one dose of vancomycin 2 grams and gentamycin 80 grams intraperitoneally.The pd nurse stated that the patient subsequently experienced abdominal pain/cloudy pd effluent fluid on approximately (b)(6) 2017.On (b)(6) 2017 the patient needed to be evaluated in the clinic again, pd effluent cultures obtained and results indicated a cell count of 8,137 and poly-morphonuclear (pmn) reported as 83% with no bacterial growth after 5 days confirming peritonitis.The pd nurse stated the patient was re-treated with the previous antibiotic therapy, reportedly with the ¿same dose and regimen¿.It was confirmed by the pd nurse the patient required outpatient treatment/management of the peritonitis event and the patient was recovering with adequate pd dialysis via ccpd therapy on the liberty cycler.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• 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: 6350160
• MDR Text Key: 68092925
• Report Number: 8030665-2017-00073
• Device Sequence Number: 1
• Product Code: FKX
• 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: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 050-87212
• Device Lot Number: 16HR08009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• 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 SOLUTION; LIBERTY CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 125