MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN- FMC CASSETTE

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

Patient Problems Myocardial Infarction (1969); Peritonitis (2252)

Event Date 07/05/2023

Event Type  Injury  

Event Description

On 07/12/2023, it was reported by a registered nurse (rn) that this patient on peritoneal dialysis (pd) has peritonitis.There were no reported allegations that the event related to any issues with fresenius products.In additional follow-up, the patient¿s pd nurse stated that the patient was experiencing symptoms of chest pressure (which did not occur during a pd treatment).As a result, on (b)(6) 2023, the patient was admitted into the hospital.The patient was diagnosed with a non st elevation myocardial infarction (nstemi).The nurse attributed the nstemi to pre-existing (prior to start of pd) comorbid condition of calciphylaxis.The nurse confirmed this cardiac event is not related to dialysis or fresenius products.Additionally, the nurse stated that during hospitalization the patient had symptoms of cloudy pd effluent.Subsequently, on (b)(6) 2023, the patient was diagnosed with peritonitis.The nurse stated the patient had a pd culture obtained but the results were not available.The patient was treated with antibiotic therapy with daptomycin (dose unknown) intra-peritoneal (ip).The nurse stated that the patient remained hospitalized (when follow-up was completed) as the patient¿s home is not conducive to pd therapy due to infection control issues.The patient¿s son will be trained to perform the pd therapy as the patient reported not being able to perform pd at home.The patient¿s nurse confirmed the patient did not have any fluid leak in relation to this event.The nurse indicated that it is highly suspected that the peritonitis was caused by breach in aseptic technique from the patient.

• Brand Name: FMC CASSETTE
• 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: 17406806
• MDR Text Key: 319876905
• Report Number: 3023981687-2023-00142
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2023,07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- FMC CASSETTE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2023
• Distributor Facility Aware Date: 07/12/2023
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 07/26/2023
• Date Manufacturer Received: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female