MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Insufficient Information (3190)

Patient Problem Hernia (2240)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted upon the completion of the plant's investigation.

Event Description

It was reported that a liberty cycler user switched treatment modalities to hemodialysis temporarily.Per the patient's nurse, this was due to surgery to correct a hernia which occurred while the patient was receiving nightly treatments on home therapy.The nurse is unable to confirm causality, and is not sure if the patient will be able to return to home therapy.The date of the hernia event or repair is not known but is prior to (b)(6) 2016.The patient currently remains on hemodialysis.

Manufacturer Narrative

The complaint device is unavailable for failure analysis investigation as the serial number is unknown.All device history records (dhr) are reviewed and released according to ¿dhr review checklist & release procedure¿, a device is not released if it does not meet requirements or is nonconforming.

Manufacturer Narrative

There is no documentation in the medical records that indicate a causal relationship between the peritoneal dialysis and/or use of fresenius products and incarcerated hernia.There is no documentation in the medical records indicating that the patient experienced iipv.There is no indication of a device malfunction.Without further information, no conclusion can be made regarding a causal relationship between the patient's peritoneal dialysis treatment and products and the incarcerated hernia.

Event Description

Medical records were made available for review.The peritoneal patient presented to the emergency room with abdominal pain, studied with a ct scan of the abdomen and pelvis.The ct scan of the abdomen and pelvis was concerning for small bowel obstruction.The physical exam and scan findings were indicative of a need for surgical intervention.The patient underwent successful repair of the incarcerated incisional hernia.The patient had somewhat labile blood pressure, and required intravenous antihypertensive to keep the blood pressure under reasonable control; nothing was given by mouth, and the patient's status was waiting return of bowel function.The patient will not be a candidate for peritoneal dialysis until there is sufficient time to heal from the repair of the incisional hernia.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5773378
• MDR Text Key: 48916519
• Report Number: 2937457-2016-00697
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR
• Patient Weight: 54