MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 050-87216

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of a drastic drop in blood pressure with subsequent disconnect from treatment and hospitalization.However, there is no documentation in the complaint file to show a causal relationship between the cardiac event and the liberty select cycler.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The patient required the surgical placement of a cardiac pacemaker due to an unspecified cardiac condition unrelated to the cycler use.Pacemakers are implanted when the electrical signal of the heart is too weak.It is unknown if the patient¿s reported abdominal infection and uti were acquired during the hospitalization or diagnosed upon admission.The abdominal infection was unspecified; however, the patient¿s antibiotic regimen is not indicative of a peritonitis diagnosis.The international society for peritoneal dialysis (ispd) recommendation for a peritonitis infection would be intraperitoneal (ip) antibiotics with vancomycin administered every 5 to 7 days for 2-3 weeks.The patient contact does not state the patient was diagnosed with peritonitis and there is no allegation of a fresenius device or other fresenius product causing the reported infection.The patient¿s uti is unrelated to pd therapy.Utis are common in pd patients and most often caused by bacteria found in the bowel and spread to the urinary tract.Based on the available information and no allegation of a malfunction, deficiency, or defect, the liberty select cycler and other fresenius product(s) can be excluded as the cause of the patient¿s drop in blood pressure with pacemaker placement, unspecified abdominal infection, and uti.

Event Description

A contact for a peritoneal dialysis (pd) patient contacted fresenius technical support requesting information on how to cancel the treatment on the liberty select cycler.The contact stated the patient was in dwell 4 and their blood pressure (bp) dropped.The fresenius technical support representative provided information on how to cancel the treatment.During follow-up the contact reported that the patient was unable to complete the treatment on (b)(6) 2021 as their bp drastically dropped (no value provided).The patient was urgently disconnected from treatment and transported via emergency medical services to the hospital.The patient was diagnosed with a weak heart (unspecified) which required the surgical placement of a cardiac pacemaker.Additionally, the patient was diagnosed with an abdominal infection (unspecified) and a urinary tract infection (uti).The patient was initiated on antibiotic therapy on (b)(6) 2021 with vancomycin 125mg every 6 hours for 10 days (route unknown).The patient was discharged on (b)(6) 2021.No additional information was provided.Attempts to reach the patient¿s pd nurse were unsuccessful.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 11318142
• MDR Text Key: 231575550
• Report Number: 8030665-2021-00210
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• 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
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 050-87216
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention