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 Chest Pain (1776); Myocardial Infarction (1969)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship between pd treatment with the fresenius cycler and the patient¿s symptoms of chest pain and subsequent hospitalization for myocardial infarction.However, there is no allegation nor any objective evidence that the patient¿s myocardial infarction.The patient is (b)(6) with reported pre-existing severe cardiac disease with history of myocardial infarction unrelated to dialysis predisposing the patient to a cardiac event.Based on all the information available, it is very likely the patient¿s myocardial infarction is associated with pre-existing comorbidities.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

On (b)(6) 2022, a patient's contact reported this 84 year old patient on peritoneal dialysis (pd) was not feeling well and needed to go to the hospital while in dwell 1 of pd treatment with the fresenius cycler.There were no reported allegations of any cycler issues or malfunctions.Rather, the caller was requesting operational assistance with how to cancel the pd treatment.In an additional follow-up call, the patient¿s pd nurse states this patient had been experiencing chest pain for hours preceding the pd treatment on (b)(6) 2022.Per the nurse, the patient stated the patient proceeded to start pd treatment (despite having the symptom) and subsequently decided to end treatment to go to the hospital.The nurse stated this patient has pre-existing severe cardiac disease with a past medical history of myocardial infarction (mi) in the past (unrelated to dialysis).The patient was admitted to the hospital for mi on (b)(6) 2022.The nurse confirmed the patient was completing pd treatments with the fresenius cycle prior to hospitalization without any issues or adverse effects.The nurse indicated the hospitalization for mi was related to the patient¿s pre-existing cardiac comorbidities and confirmed the event was not related to dialysis or fresenius products.The patient reportedly is continuing pd treatments with the same cycler.

Event Description

On 26/mar/2022, a patient's contact reported this 84 year old patient on peritoneal dialysis (pd) was not feeling well and needed to go to the hospital while in dwell 1 of pd treatment with the fresenius cycler.There were no reported allegations of any cycler issues or malfunctions.Rather, the caller was requesting operational assistance with how to cancel the pd treatment.In an additional follow-up call, the patient¿s pd nurse states this patient had been experiencing chest pain for hours preceding the pd treatment on 26/mar/2022.Per the nurse, the patient stated the patient proceeded to start pd treatment (despite having the symptom) and subsequently decided to end treatment to go to the hospital.The nurse stated this patient has pre-existing severe cardiac disease with a past medical history of myocardial infarction (mi) in the past (unrelated to dialysis).The patient was admitted to the hospital for mi on 27/mar/2022- 29/mar/2022.The nurse confirmed the patient was completing pd treatments with the fresenius cycle prior to hospitalization without any issues or adverse effects.The nurse indicated the hospitalization for mi was related to the patient¿s pre-existing cardiac comorbidities and confirmed the event was not related to dialysis or fresenius products.The patient reportedly is continuing pd treatments with the same cycler.

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-conformance's, 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.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14058810
• MDR Text Key: 289611690
• Report Number: 0002937457-2022-00597
• 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,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2011
• 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
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male