MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Use of Device Problem (1670)

Patient Problem Peritonitis (2252)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - the device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's husband reported the patient was not draining and had been experiencing unusual drain pain.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient¿s abdominal pain was due to an episode of peritonitis in which the patient was diagnosed with when the patient came into the clinic (b)(6) 2016.Per pdrn the patient had reported experiencing drain pain during treatment and was requested to bring her effluent into clinic, which the patient did not notice was cloudy but was confirmed as cloudy when observed in clinic.Per pdrn she had spoken with the patient¿s husband regarding the incident and stated the infection was attributed to touch contamination, where the patient had breaks in technique and sterility, and indicated the patient did not practice aseptic technique during treatment: the patient did not don a mask.There were no reported fluid leaks during treatment prior to infection.The pdrn stated the patient will be re-trained on performing continuous cycler-assisted peritoneal dialysis (ccpd) therapy with the cycler due to the infection.Per pdrn the patient was being treated in-clinic and continued to use continuous cycler-assisted peritoneal dialysis (ccpd) therapy with the cycler.Medical records were requested.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Manufacturer Narrative

Although a temporal association between the liberty cycler and the event of abdominal pain with associated peritonitis exist, there is no documentation that shows a causal relationship between the event of abdominal pain and the subsequent diagnosis of peritonitis and the liberty cycler.Additionally, there is no allegation against any fresenius products and the event.There is however a probable association between the breach in aseptic technique during ccpd treatment and the episode of peritonitis.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.It was reported this end stage renal disease (esrd) patient on continuous cyclic peritoneal dialysis (ccpd) experienced abdominal pain during her ccpd treatment.The patient brought her effluent to the clinic which was noted to be cloudy and the patient was subsequently diagnosed with peritonitis.The patient was being treated (course of treatment unknown) for the peritonitis at the clinic.The patient's nurse attributed the peritonitis to touch contamination, stating the patient had breaks in technique and sterility and did not practice aseptic technique during treatment; not donning a mask.The patient was being re-trained.There were no reported fluid leaks during treatment prior to infection.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6135708
• MDR Text Key: 61138867
• Report Number: 2937457-2016-01192
• 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 Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR