MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number CYCLER SET

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Peritonitis (2252); Abdominal Distention (2601); Constipation (3274)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

There is a temporal relationship between ccpd therapy on the liberty cycler and the patient¿s adverse event of peritonitis.However, there is no objective evidence that indicates the liberty cycler malfunctioned or did not meet performance expectations causing the patient¿s adverse event.Additionally there is no allegation the liberty cycler did not perform as intended.The etiology of the patient¿s peritonitis is unknown, and additional attempts at obtaining information have been unsuccessful.Therefore, based on the information available, causality cannot be determined.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Medical records received for an unrelated customer experience indicates that the peritoneal dialysis patient was hospitalized for peritonitis on (b)(6) 2018 and discharged on (b)(6) 2018.It is unknown if the patient encountered any device malfunctions at the time.The record states the patient was hospitalized for peritonitis (details unknown) and was treated with augmentin (duration, dosage, frequency and route unknown).It is unknown if any fresenius device(s) or product(s) were utilized during the hospitalization.Additional information has been solicited.

Event Description

Additional information was solicited and received.The discharge summary was received on 19/jun/2018 which revealed the patient presented to the emergency room (er) with diffuse abdominal pain, abdominal distention, and chest pain for 10 days.The patient was reportedly seen two weeks prior (exact date unknown) by a physician (specialty unknown) for the chest pain and underwent a ventilation perfusion (vq) scan; which was negative.The patient was treated with an azithromycin pack x 2 without effect.The patient also reported experiencing constipation and belching for the past week.A computed tomography (ct) scan of the abdomen was performed and was significant for peritonitis and enteritis.The patient was started on augmentin (dosage, route, frequency and duration unknown), however the abdominal pain continued.On (b)(6) 2018 a second ct scan showed a possible abscess (cause unknown); for which he received jackson-pratt drain on (b)(6) 2018.All cultures (source unknown) reportedly remained negative and the abdominal pain gradually improved.During course of the hospitalization it appears the patient¿s peritoneal dialysis catheter (not a fresenius product) became obstructed and required cathflo (dosage unknown), however the patient was able to tolerate pd prior to discharge.The patient was discharged with orders to continue the augmentin, and to follow up with nephrology in the next two weeks.It is unknown if any fresenius device(s) or product(s) were utilized during the hospitalization.Of note: the patient underwent an esophagogastroduodenoscopy (egd) during the hospitalization for epigastric pain which revealed gastritis.

Manufacturer Narrative

Clinical review: there is a temporal relationship between ccpd therapy utilizing the liberty cycler, liberty cycler set and the patient¿s adverse event(s) of constipation, belching, chest pain, abdominal pain, abdominal distention, peritonitis and possible abdominal abscess which required hospitalization and subsequent antibiotic therapy and jackson-pratt drain insertion.However, there is no objective evidence or allegation that indicates the liberty cycler and/or liberty cycler set malfunctioned or failed to meet performance expectations thus causing or contributing to the patient¿s adverse event(s).The etiology of the constipation is unknown, therefore causality cannot be determined.It is known however that dialysis patients have a high incidence of constipation attributed to a multitude of factors (3).The etiology of the gastritis, belching, abdominal pain and abdominal distention is unknown, therefore causality cannot be determined.However, while the etiology for the gastritis is unknown, the common side effects of gastritis include abdominal pain, abdominal distention, belching and chest pain (2).The etiology of the peritonitis and abdominal abscess is also unknown, therefore causality cannot be determined.It should be noted though that peritoneal dialysis therapy is consummate with a higher rate of infection of the peritoneum (1).Therefore, based on the information available, causality cannot be determined.Should additional information become available, the new information will be evaluated accordingly.

Event Description

".".

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.All companion samples have been sold and distributed.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history 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
• MDR Report Key: 7544084
• MDR Text Key: 109229849
• Report Number: 8030665-2018-00776
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CYCLER SET
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; AUGMENTIN; EPOGEN; LABETALOL; LIBERTY CYCLER; LIBERTY CYCLER SET; NORVASC; PROTONIX; VELPHORO; VITAMIN D; ZESTRIL; LIBERTY CYCLER; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR