MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SAFE LOCK APD LUER LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	050-95018
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Abdominal Pain (1685); Peritonitis (2252)
Date of Event	05/10/2021
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 investigation: a temporal relationship exists between the pd therapy with the fresenius apd adaptor and the patient¿s peritonitis event.The patient¿s pd nurse reported that prior to the peritonitis event, the patient experienced a fluid leak from a loose connection between the fresenius apd adaptor and the baxter icodextrin pd solution (not a fresenius product).Additionally, the nurse stated the patient tried to secure the connection with an ungloved hand.The apd adaptor used during the event is not available for return to manufacturer for further analysis.Currently, it cannot be determined if the connection was secured properly by the patient or if there was a product deficiency with the baxter icodextrin solution connection and/or the fresenius adaptor connection.Based on the available information, the patient¿s peritonitis can be reasonably attributed to a breach in the sterility of the pd circuit due to the reported fluid leak and handling the connection between the fresenius apd adaptor and the baxter icodextrin pd solution (not a fresenius product.With ungloved hands.Therefore, the fresenius apd adaptor cannot be excluded from the peritonitis event.
Event or Problem Description
It was reported that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.During additional follow-up, the patient¿s pd nurse stated that on 10/may/2021 the patient was hospitalized with symptoms of abdominal pain.It was reported the patient was admitted with peritonitis as the patient¿s pd culture (date unknown) which yielded growth of the organism klebsiella.During hospitalization, the patient was treated with the antibiotic rocephin intra-peritoneal (ip).Additionally, it was reported the patient initially continued pd in the hospital.However, the patient was not able to continue pd herself due to overall malaise from the peritonitis infection and as a result the patient was subsequently transitioned to hemodialysis.On (b)(6) 2021, the patient was discharged from the hospital to a rehabilitation facility.The patient remains on hemodialysis currently and is recovering from the peritonitis infection, per the nurse.The nurse reported that on an unknown date (prior to hospitalization) the connection between the fresenius apd adaptor and the baxter icodextran pd solution (not a fresenius product became loose and caused a fluid leak.It was also reported the patient tried to fix the connection with ungloved hands.The nurse indicated the peritonitis was attributed to a fluid leak between the fresenius apd adaptor and the baxter icodextran pd solution (not a fresenius product).The nurse reported it cannot be confirmed if the connection was not secured by the patient or if there was a product deficiency with the baxter icodextran solution connection and/or the fresenius adaptor connection.Reportedly, the fresenius adaptor is not available for return to manufacturer for further analysis.
Additional Manufacturer Narrative
Corrected information: d10: removing concomitant product- delflex pd fluid 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 apd luer lock connectors 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 or Problem Description
It was reported that this patient on peritoneal dialysis (pd) was hospitalized with peritonitis.During additional follow-up, the patient¿s pd nurse stated that on (b)(6) 2021 the patient was hospitalized with symptoms of abdominal pain.It was reported the patient was admitted with peritonitis as the patient¿s pd culture (date unknown) which yielded growth of the organism klebsiella.During hospitalization, the patient was treated with the antibiotic rocephin intra-peritoneal (ip).Additionally, it was reported the patient initially continued pd in the hospital.However, the patient was not able to continue pd herself due to overall malaise from the peritonitis infection and as a result the patient was subsequently transitioned to hemodialysis.On (b)(6) 2021, the patient was discharged from the hospital to a rehabilitation facility.The patient remains on hemodialysis currently and is recovering from the peritonitis infection, per the nurse.The nurse reported that on an unknown date (prior to hospitalization) the connection between the fresenius apd adaptor and the baxter icodextran pd solution (not a fresenius product became loose and caused a fluid leak.It was also reported the patient tried to fix the connection with ungloved hands.The nurse indicated the peritonitis was attributed to a fluid leak between the fresenius apd adaptor and the baxter icodextran pd solution (not a fresenius product).The nurse reported it cannot be confirmed if the connection was not secured by the patient or if there was a product deficiency with the baxter icodextran solution connection and/or the fresenius adaptor connection.Reportedly, the fresenius adaptor is not available for return to manufacturer for further analysis.

• Brand Name: SAFE LOCK APD LUER LOCK CONNECTOR
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 11974804
• Report Number: 8030665-2021-00995
• Device Sequence Number: 3388334
• Product Code: KDJ
• UDI-Device Identifier: 00840861100811
• UDI-Public: 00840861100811
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K124024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95018
• Device Catalogue Number: 050-95018
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR