MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY DRAIN LINE, LUER TAPER CONN. 30; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number	026-20036A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: it was confirmed the patient¿s fall over their drain line, fluid removal from their knees and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler with plans to transition to in-center hd in the near future.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
The peritoneal dialysis (pd) patient reported that they fell down after tripping over the drain line from the previous night¿s treatment.The patient required assistance with getting up and presented to the emergency room (er) to have fluid drained from their knees.The patient confirmed that they were not connected to the cycler when the event occurred.The patient¿s pd registered nurse stated during followup that the patient¿s fall was due to a history of lower extremity weakness that is related to cardiovascular disease and unrelated to pd therapy.It was stated any fluid that had to be removed was due to fluid retention from poorly controlled congestive heart failure.Additionally, it was reported the patient has advancing end-stage renal disease with membrane failure.The patient plans to transition to hemodialysis (hd) for renal replacement therapy as pd is no longer sufficient.It was confirmed the patient¿s fall over their drain line, fluid removal from their knees and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler with plans to transition to in-center hd in the near future.
Event or Problem Description
The peritoneal dialysis (pd) patient reported that they fell down after tripping over the drain line from the previous night¿s treatment.The patient required assistance with getting up and presented to the emergency room (er) to have fluid drained from their knees.The patient confirmed that they were not connected to the cycler when the event occurred.The patient¿s pd registered nurse stated during followup that the patient¿s fall was due to a history of lower extremity weakness that is related to cardiovascular disease and unrelated to pd therapy.It was stated any fluid that had to be removed was due to fluid retention from poorly controlled congestive heart failure.Additionally, it was reported the patient has advancing end-stage renal disease with membrane failure.The patient plans to transition to hemodialysis (hd) for renal replacement therapy as pd is no longer sufficient.It was confirmed the patient¿s fall over their drain line, fluid removal from their knees and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received liberty select cycler with plans to transition to in-center hd in the near future.
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 drain line 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.A review of the user guide was performed.At this time, the reported incident could be attributed to end user error in accordance with the complaint description.As the complaint sample was not available a physical evaluation could not be performed, therefore the alleged event could not be confirmed.

• Brand Name: LIBERTY DRAIN LINE, LUER TAPER CONN. 30
• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12878193
• Report Number: 8030665-2021-01779
• Device Sequence Number: 14561673
• Product Code: KDJ
• UDI-Device Identifier: 00840861101115
• UDI-Public: 00840861101115
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K915628
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 026-20036A
• Device Catalogue Number: 026-20036A
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 12/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 133 KG