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

Catalog Number 050-87216

Device Problem Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with drain lines and the patient event of tripping, falling and breaking an ankle.There is a possible causal relationship between the event and the liberty select cycler and drain lines as the low flow alarm was keeping the patient awake resulting in her moving the cycler from bedside.It is unknown if the patient would have tripped had the cycler not been moved.The fresenius liberty select cycler user¿s guide cautions patients about the tripping hazard of the drain line.Based on the available information, the drain lines cannot be excluded as the cause of the patient fall and broken ankle.

Event Description

A peritoneal dialysis (pd) nurse reported that a patient went to the hospital and required surgery after they broke their ankle when they tripped on the liberty cycler set's drain line.The patient was at the end of treatment on (b)(6) 2019 with the liberty select cycler when she got up and tripped over the drain line.The patient¿s cycler kept alarming with low flow alarms which was keeping the patient awake.As a result, the cycler was relocated from the side of the patient¿s bed to the bathroom.The patient had to walk to the bathroom to disconnect from treatment when the tripping incident occurred.The patient was transported via emergency medical services (ems) to the hospital where she was diagnosed with a broken ankle.She was sent home with an appointment to see the surgeon.On (b)(6) 2019 the patient underwent surgery and was kept for 24 hours observation.The patient is home recovering with a boot for her ankle and continues to complete pd treatment on the liberty select cycler.No further information was available.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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

A peritoneal dialysis (pd) nurse reported that a patient went to the hospital and required surgery after they broke their ankle when they tripped on the liberty cycler set's drain line.The patient was at the end of treatment on (b)(6) 2019 with the liberty select cycler when she got up and tripped over the drain line.The patient¿s cycler kept alarming with low flow alarms which was keeping the patient awake.As a result, the cycler was relocated from the side of the patient¿s bed to the bathroom.The patient had to walk to the bathroom to disconnect from treatment when the tripping incident occurred.The patient was transported via emergency medical services (ems) to the hospital where she was diagnosed with a broken ankle.She was sent home with an appointment to see the surgeon.On (b)(6) 2019 the patient underwent surgery and was kept for 24 hours observation.The patient is home recovering with a boot for her ankle and continues to complete pd treatment on the liberty select cycler.No further information was available.

• 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: 8954095
• MDR Text Key: 160865982
• Report Number: 8030665-2019-01385
• 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
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 050-87216
• Device Lot Number: 19ER08081
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY SELECT CYCLER
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR