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

Catalog Number RTLR180111

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

Patient Problems Seizures (2063); Vomiting (2144); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi): (b)(4) - 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.Clinical review of the medical records do not reveal any allegation or malfunction of fresenius products.The patient has complex comorbidities and newly diagnosed brain tumor and subsequent episodes of seizures.The pneumoperitoneum was likely related to the ruptured diverticula and unlikely related to peritoneal dialysis with fresenius products.The seizure activity was likely related to the new diagnosis of a space occupying lesion, probably meningioma, and unlikely related to related to peritoneal dialysis with fresenius products.

Event Description

A peritoneal dialysis (pd) patient's husband reported his wife was in the hospital vomiting and it has been happening for the past year.He believed it was due to the air in the abdomen which was caused by the pd treatment.Additional information provided by the pd patient's clinic registered nurse (pdrn) revealed the patient was admitted to the hospital on (b)(6) 2016.The patient was experiencing vomiting, seizures and had a fracture.The pdrn further informed that the patient has a brain tumor and that might be the reason for her seizures.However, she further added that the patient¿s husband is of the opinion that the seizures are due to the air in the abdomen which is caused by the pd treatment.He informed the pdrn that the physicians at the hospital feel the same that the issues are due to pd treatment and not brain tumor.She further added that the patient has a history of acid reflex, gi work up, gastritis and esophagitis which could be the reason behind her vomiting.The patient started her treatment from (b)(6) 2015.The pdrn reported she was not very confident on what the patient¿s husband was informing her as she did not see any of the hospital reports.She said that last time she spoke to the patient¿s husband he told her that the patient was recovering.The following is from medical records received from the patient¿s treatment facility.This (b)(6) female with end stage renal disease (esrd), peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2016 with vomiting.A pneumoperitoneum (the admitting diagnosis) was identified on computerized tomography (ct) abdominal scan.The history and physical dated (b)(6) 2016, list pneumoperitoneum possibly due to pd catheter, with no peritonitis or no evidence of an acute abdomen.On (b)(6) 2016, the patient experienced a witnessed seizure like event lasting one to two minutes.The convulsive activity resolved on its own.The patient underwent head ct scan which revealed a dural based 3.6cm mass along the falx with peripheral calcification likely representing a meningioma.The patient was also noted to have lactate acidosis.The patient was transferred to surgical intensive care unit (sicu).The patient was alert and oriented.Shortly after arrival the patient began to have full body symmetric convulsions (seizure activity).The patient received ativan 2mg and was ultimately intubated for low glasgow coma scale (gcs) and airway protection and place on mechanical ventilation.The patient was also treated with keppra for seizure activity.On (b)(6) 2016 ct of the abdomen showed the pneumoperitoneum had resolved.

Manufacturer Narrative

(b)(4) (pneumoperitoneum).

• 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: 6215818
• MDR Text Key: 63651070
• Report Number: 2937457-2016-01271
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• 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
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2009
• 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; DIPHENHYDRAMINE; HYDROMORPHONE; LIBERTY CYCLER CASSETTE; LORAZEPAM; ONDANSETRON; OXYCODONE-ACETAMINOPHEN
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 51