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 Abdominal Pain (1685); Fatigue (1849); Peritonitis (2252)

Event Date 05/16/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.However, there is no allegation nor any objective evidence that a liberty cycler set malfunction or product deficiency was associated with this event.Peritonitis is a well-documented complication in patients undergoing pd therapy.A breach in aseptic technique during the pd exchange is a common finding and a significant risk factor for infection.Based on the reported information, the patient¿s peritonitis can be reasonably attributed touch contamination during the pd exchange, as reported by the patient¿s nurse.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient is currently in the clinic to be treated for peritonitis, which is likely cause of increased fibrin production.Upon follow up, the patient¿s pd nurse reported the patient went to the emergency room (er) for symptoms of abdominal pain and general weakness.A pd culture was obtained (the same day) which yielded no organism, and an elevated white blood cell (wbc) count of 143.The nurse stated the patient was not admitted to the hospital.The patient was discharged home< than 24 hours on antibiotic therapy with vancomycin and ceftazidime intra-peritoneal (ip) on an outpatient basis.Subsequently, on (b)(6) 2021, the patient was seen in the outpatient pd clinic.A repeat a pd cell count was obtained which showed the wbc was normal (24).Additionally, it was reported the patient had fibrin (due to peritonitis) which was managed with use of heparin (per patient standing orders).The patient is recovering from the event and continues pd treatment with the same cycler, according to the nurse.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse stated the peritonitis was attributed to touch contamination during the pd exchange.

Event Description

It was reported that a peritoneal dialysis (pd) patient is currently in the clinic to be treated for peritonitis, which is likely cause of increased fibrin production.Upon follow up, the patient¿s pd nurse reported the patient went to the emergency room (er) for symptoms of abdominal pain and general weakness.A pd culture was obtained (the same day) which yielded no organism, and an elevated white blood cell (wbc) count of 143.The nurse stated the patient was not admitted to the hospital.The patient was discharged home< than 24 hours on antibiotic therapy with vancomycin and ceftazidime intra-peritoneal (ip) on an outpatient basis.Subsequently, on (b)(6) 2021, the patient was seen in the outpatient pd clinic.A repeat a pd cell count was obtained which showed the wbc was normal (24).Additionally, it was reported the patient had fibrin (due to peritonitis) which was managed with use of heparin (per patient standing orders).The patient is recovering from the event and continues pd treatment with the same cycler, according to the nurse.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse stated the peritonitis was attributed to touch contamination during the pd exchange.

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.In addition, the user guide was reviewed and states as a warning before starting the treatment, ¿you must use aseptic technique as directed by your pd nurse to prevent infection¿.At this time the reported incident could be attributed to end user error in accordance to the complaint description.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.

Manufacturer Narrative

Correction: h6 clinical code missing "fatigue" in initial report.

Event Description

It was reported that a peritoneal dialysis (pd) patient is currently in the clinic to be treated for peritonitis, which is likely cause of increased fibrin production.Upon follow up, the patient¿s pd nurse reported the patient went to the emergency room (er) for symptoms of abdominal pain and general weakness.A pd culture was obtained (the same day) which yielded no organism, and an elevated white blood cell (wbc) count of 143.The nurse stated the patient was not admitted to the hospital.The patient was discharged home< than 24 hours on antibiotic therapy with vancomycin and ceftazidime intra-peritoneal (ip) on an outpatient basis.Subsequently, on (b)(6) 2021, the patient was seen in the outpatient pd clinic.A repeat a pd cell count was obtained which showed the wbc was normal (24).Additionally, it was reported the patient had fibrin (due to peritonitis) which was managed with use of heparin (per patient standing orders).The patient is recovering from the event and continues pd treatment with the same cycler, according to the nurse.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device, or product in relation to the event.The nurse stated the peritonitis was attributed to touch contamination during the pd exchange.

• 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: 11913256
• MDR Text Key: 253542131
• Report Number: 8030665-2021-00939
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/10/2021; 06/16/2021
• Supplement Dates FDA Received: 06/14/2021; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR