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  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between the pd therapy with the liberty select cycler/ liberty cycler set and the patient¿s hospitalization for myocardial infarction and peritonitis.Currently, there is no allegation nor any objective evidence that a liberty select cycler/ liberty cycler set malfunction or product deficiency was associated with the events.Peritonitis is a well-documented complication in patients undergoing pd therapy.Based on the reported information, the exact cause for the patient¿s peritonitis cannot be identified.However, the patient¿s pd nurse stated it is suspected the patient caused a breach in aseptic technique as the patient¿s home had report of infection control issues as well as the patient not being able to perform pd therapy.Moreover, the patient had pre-existing comorbid condition of calciphylaxis which is a significant risk factor for cardiac disease.There were no reported allegations that the patient¿s myocardial infarction occurred during a pd treatment or was related to any issues with fresenius products.With the information available, the patient¿s myocardial infarction can be reasonably attributed to pre-existing comorbid condition of calciphylaxis.

Event Description

On (b)(6) 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.

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-conformances 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.

Event Description

On (b)(6) 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17406805
• MDR Text Key: 319871176
• Report Number: 0008030665-2023-00672
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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
• Device Age: MO
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female