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

Model Number 180343

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

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

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.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11318078
• MDR Text Key: 231901028
• Report Number: 2937457-2021-00237
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2021

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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2017
• 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