MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

Catalog Number 050-87216

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

Patient Problems Pneumonia (2011); Vomiting (2144)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

The patient's medical records were requested and had not been received at the time of this report.A supplemental report will be submitted upon completion of plant's investigation.This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.

Event Description

The peritoneal dialysis (pd) patient's wife requested assistance canceling the patient's treatment because the patient had to go to the emergency room (er) due to pneumonia.The patient's wife stated the pneumonia was not related to the liberty cycler.The patient's wife mentioned the patient was spitting up a few minutes ago while he was connected to the cycler.During a follow-up, the pd registered nurse (rn) stated the patient was being treating with antibiotics orally.The pdrn stated the patient has an ongoing issue with vomiting during his pd treatments.The pdrn stated there was no evidence of fluid overload or problem's with the patient's pd therapy.The patient was seen in the emergency room several times for less than 24 hours, but he was not admitted until (b)(6) 2015 for nausea and vomiting.The patient was discharged on (b)(6) 2015.The pdrn believes the patient's hospitalization was related to his ongoing issue with pneumonia, but she did not have his discharge information.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The complaint device lot number was not reported, however the sales and shipping records for the patient were reviewed for three months prior to the date of occurrence.No product was available from these lots in distribution centers to be analyzed, as the entirety of the lots have been sold and distributed.Device history review was performed on the potential related lots.No non-conformance reports or other abnormalities during the manufacturing process were found for these lots.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler device and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

Manufacturer Narrative

Review of medical records revealed that the patient managed their own insulin administration during the admission via an insulin pump and may not have adjusted insulin for an esophagogastroduodenoscopy.On (b)(6) 2015, the patient was discharged from the hospital to home in stable condition.The patient's pd nurse stated that there was no evidence of fluid overload or problem's with the patient's pd therapy and the patient's hospitalization was related to his ongoing issue with pneumonia.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products and the events of pneumonia, intractable nausea and vomiting, and outcome of hospitalization.

Event Description

The following is from medical records provided by the patient's treatment facility.The patient presented to a hospital with recurrent problems with epigastric discomfort and intractable nausea and vomiting that occurred intermittently but recurrently.During the admission, the patient was treated with antiemetics; drug name, dose, route and frequency not reported.On (b)(6) 2015, the patient experienced a severe hypoglycemic reaction; a rapid response was called, the blood glucose was 20, the patient was diaphoretic, one ampule of dextrose 50% was administered via intravenous (iv) route, and the patient slowly became responsive, alert, and returned back to his baseline status with blood glucose levels in the 140-220 range.The patient managed their own insulin administration during the admission via an insulin pump and may not have adjusted insulin for an esophagogastroduodenoscopy.On (b)(6) 2015, the patient was discharged from the hospital to home in stable condition.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT,; parque ind. reynosa sur, brecha e-99 ; apartado postal #326; reynosa, tamps, cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5357049
• MDR Text Key: 35617052
• Report Number: 8030665-2016-00010
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2016

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: 050-87216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2016; 04/20/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 83