MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE PATIENT CONN; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	050-87215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.Currently, 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.The patient¿s pd culture grew the bacteria streptococcus mitis which is found in the oropharynx of humans.Based on the reported information, the patient¿s peritonitis was associated with a breach in aseptic technique during the pd exchange as the patient was not wearing a mask for the pd procedure.
Event or Problem Description
On 29/nov/2023, this patient on peritoneal dialysis (pd) therapy reported she had peritonitis the first week of november.There were no reported allegations that the peritonitis was related to any issues with fresenius products.The patient reported she was not hospitalized and received antibiotic treatment.In additional follow-up, the patient¿s pd nurse confirmed that on (b)(6) 2023, the patient was seen in the outpatient pd clinic for symptoms of abdominal pain.The patient had a pd culture obtained which grew the bacteria streptococcus mitis.The patient was treated with intra-peritoneal (ip antibiotic therapy with vancomycin (dose not provided) and ceftazidime (dose not provided) on an outpatient basis.The patient has recovered and is completing pd treatment with the same cycler.The nurse confirmed the patient did not have any fluid leaks or any issues with fresenius products in relation to the peritonitis event.The nurse attributed the peritonitis to a breach in aseptic technique as the patient was not wearing a mask during the pd procedure.
Additional 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.Based in the complaint description and information provided the reported peritonitis was attributed to a breach in aseptic technique.There is no allegation of cassette malfunction.As there is no allegation related to product manufacture, the complaint is deemed as unconfirmed.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 or Problem Description
On (b)(6) 2023, this patient on peritoneal dialysis (pd) therapy reported she had peritonitis the first week of november.There were no reported allegations that the peritonitis was related to any issues with fresenius products.The patient reported she was not hospitalized and received antibiotic treatment.In additional follow-up, the patient¿s pd nurse confirmed that on (b)(6) 2023, the patient was seen in the outpatient pd clinic for symptoms of abdominal pain.The patient had a pd culture obtained which grew the bacteria streptococcus mitis.The patient was treated with intra-peritoneal (ip antibiotic therapy with vancomycin (dose not provided) and ceftazidime (dose not provided) on an outpatient basis.The patient has recovered and is completing pd treatment with the same cycler.The nurse confirmed the patient did not have any fluid leaks or any issues with fresenius products in relation to the peritonitis event.The nurse attributed the peritonitis to a breach in aseptic technique as the patient was not wearing a mask during the pd procedure.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Common Device Name: 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: 18294939
• Report Number: 0008030665-2023-01121
• Device Sequence Number: 7035351
• Product Code: FKX
• UDI-Device Identifier: 00840861100743
• UDI-Public: 00840861100743
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-87215
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female