MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

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

Patient Problems Abdominal Pain (1685); Dehydration (1807); Encephalopathy (1833); Cognitive Changes (2551)

Event Date 09/04/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Medical records were received and it was discovered the patient was hospitalized from (b)(6) 2017 for toxic metabolic encephalopathy.

Manufacturer Narrative

Conclusion: there is no documentation that shows a causal relationship between the adverse event of altered mental status and the hospitalization and the liberty cycler.The patient was transported from a rehab facility where it is unknown if the patient was completing pd therapy or if any fresenius products were being utilized.There is a temporal relationship between esrd and toxic metabolic encephalopathy which can be the result of organ failure and toxins from medications.The body chemicals, hormones and electrolytes are out of balance and can impact the brain¿s function.Once the toxins are removed, such as in dialysis, the imbalance is restored and the encephalopathy is resolved.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file and hospital discharge summary was reviewed by a post market surveillance clinician.On (b)(6) 2017, this patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) stated that he had been hospitalized for approximately five weeks and had been home for about a week with no issues during ccpd therapy treatments.Review of the medical records revealed the patient was admitted to the hospital from rehab on (b)(6) 2017 for altered mentation and diagnosed with toxic metabolic encephalopathy (possibly from medication), dehydration, adrenal insufficiency, abdominal pain and metabolic acidosis.The patient was highly alerted, agitated and had myoclonic jerks and was currently prescribed trileptal and trazodone from his psychiatrist and was also completing augmentin for the previous peritonitis event.The patient underwent a cosyntropin stimulation test to monitor for adrenal insufficiency and did not pass.He was then prescribed prednisone 10mg for two weeks and then 5mg for two weeks (route unknown).The patient¿s computerized tomography (ct) head scan was unremarkable and ct abdomen scan showed the pd catheter (not a fresenius product) with small amount of fluid.The patient was transitioned to hemodialysis in hospital for two treatments.It is unknown if fresenius products were utilized.The patient improved clinically and mentation went back to normal limits.The cause of the altered mentation is unknown, but excess medication is suspected as a potential cause of the event.The pd fluid culture was unremarkable and the patient discontinued antibiotic regimen.The patient was cautioned on the overuse of oxycodone and overdosing, but adamantly denied that being an issue.The patient was discharged to home, per patient request, on (b)(6) 2017 with physical therapy (pt) and occupational therapy (ot) orders and to continue pd therapy treatment.Per the pdrn, the patient had recovered and looked ¿much better¿.

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-conformance 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.

Event Description

Information in the complaint file and hospital discharge summary was reviewed by a post market surveillance clinician.On (b)(6) 2017, this patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) stated that he had been hospitalized for approximately five weeks and had been home for about a week with no issues during ccpd therapy treatments.Review of the medical records revealed the patient was admitted to the hospital from rehab on (b)(6) 2017 for altered mentation and diagnosed with toxic metabolic encephalopathy (possibly from medication), dehydration, adrenal insufficiency, abdominal pain and metabolic acidosis.The patient was highly alerted, agitated and had myoclonic jerks and was currently prescribed trileptal and trazodone from his psychiatrist and was also completing augmentin for the previous peritonitis event.The patient underwent a cosyntropin stimulation test to monitor for adrenal insufficiency and did not pass.He was then prescribed prednisone 10mg for two weeks and then 5mg for two weeks (route unknown).The patient¿s computerized tomography (ct) head scan was unremarkable and ct abdomen scan showed the pd catheter (not a fresenius product) with small amount of fluid.The patient was transitioned to hemodialysis in hospital for two treatments.It is unknown if fresenius products were utilized.The patient improved clinically and mentation went back to normal limits.The cause of the altered mentation is unknown, but excess medication is suspected as a potential cause of the event.The pd fluid culture was unremarkable and the patient discontinued antibiotic regimen.The patient was cautioned on the overuse of oxycodone and overdosing, but adamantly denied that being an issue.The patient was discharged to home, per patient request, on (b)(6) 2017 with physical therapy (pt) and occupational therapy (ot) orders and to continue pd therapy treatment.Per the pdrn, the patient had recovered and looked ¿much better¿.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• 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: 6898064
• MDR Text Key: 87589828
• Report Number: 2937457-2017-00962
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 09/28/2017; 09/29/2017
• Supplement Dates FDA Received: 09/28/2017; 10/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 103