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 Sepsis (2067); Septic Shock (2068); Peritonitis (2252)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Although a temporal relationship exists between the liberty cycler, liberty cycler set and the reported adverse event(s) of peritonitis, septic shock and subsequent hospitalization, there is no documentation or evidence indicating a causal relationship between the liberty cycler and/or liberty cycler set and the adverse event(s).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) of peritonitis leading to septic shock and a breach in aseptic technique during therapy as reported by the pdrn on (b)(6) 2018.A supplemental mdr will be submitted upon device evaluation.Mdrs 8030665-2018-00181, 8030665-2018-00182, and this report are 3 events for the same patient due to an ongoing peritonitis event.

Event Description

During a follow-up call for reported drain complications on (b)(6) 2018 the peritoneal dialysis registered nurse (pdrn) stated the patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized from (b)(6) 2017 for peritoneal dialysis catheter removal/repair, peritonitis, and subsequent septic shock (signs/symptoms unknown).During a follow-up call on 31/jan/2018 the pdrn reported the catheter¿s ¿cuff¿ has been exposed since (b)(6) 2017, and could not have been repaired prior to (b)(6) 2017, as the patient had active peritonitis.The patient was admitted to the hospital on (b)(6) 2017 and the pdrn reported a culture was obtained (collection site, collection date and result date unknown) which was positive for klebsiella (species unknown).Additionally a cell count (collection site, collection date and result date unknown) showed an elevated white blood cell count (wbc) of 16.89 x10^9/l.The patient was treated with vancomycin (route, dose, duration and frequency unknown).The pdrn reported the peritonitis was caused touch contamination due to the patient¿s vision impairment and the catheter cuff showing allowing ¿bugs a place to hide from the antibiotics.¿ the pd catheter was removed on (b)(6) 2017, and the patient transitioned to hemodialysis (hd) on (b)(6) "2018".It is unknown if any fresenius device(s) or product(s) were utilized during the hospitalization.The hospital course is largely unknown, as is the discharge disposition of the patient.Per the pdrn, as of (b)(6) 2018 the patient continues to receive in-center hemodialysis (ichd), and has been admitted to a skilled nursing facility (snf) due to an inability to perform self-care.

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: 7238032
• MDR Text Key: 98910281
• Report Number: 8030665-2018-00183
• 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

• Date FDA Received: 02/02/2018
• 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: 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): Hospitalization; Required Intervention
• Patient Age: 58 YR