MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 11/01/2021

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient reported having an umbilical hernia and having gas.In a follow up with the pd registered nurse (rn), the hernia was indicated as being pre-existing prior to the start of pd therapy on (b)(6) 2020.It was confirmed the patient¿s hernia has not worsened with pd treatments and there was no increase in swelling/size of the hernia and no associated pain.Currently, the hernia is being watched as the hernia itself is not reducible, per the nurse.The nurse reported the patient is completing pd treatment with the fresenius cycler without any adverse effects or cycler malfunctions.The pd nurse indicated the hernia has not required any medical intervention.The cycler is not available to be returned for manufacturer evaluation.

Manufacturer Narrative

Clinical review: the pd nurse indicated the hernia has not required any medical intervention.The nurse stated the hernia was pre-existing prior to the start of pd therapy on (b)(6) 2020.It was confirmed the patient¿s hernia has not worsened with pd treatments and there was no increase in swelling/size or the hernia and no associated pain.Currently, the hernia is being watched as the hernia itself is not reducible, per the nurse.The nurse reported the patient is completing pd treatment with the fresenius cycler without any adverse effects or cycler malfunctions.Based on the available information, there is no allegation or objective evidence that a fresenius device or product issue caused or contributed to a serious patient harm or injury.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A peritoneal dialysis (pd) patient reported having an umbilical hernia and having gas.In a follow up with the pd registered nurse (rn), the hernia was indicated as being pre-existing prior to the start of pd therapy on (b)(6) 2020.It was confirmed the patient¿s hernia has not worsened with pd treatments and there was no increase in swelling/size of the hernia and no associated pain.Currently, the hernia is being watched as the hernia itself is not reducible, per the nurse.The nurse reported the patient is completing pd treatment with the fresenius cycler without any adverse effects or cycler malfunctions.The pd nurse indicated the hernia has not required any medical intervention.The cycler is not available to be returned for manufacturer evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13010955
• MDR Text Key: 282277997
• Report Number: 2937457-2021-02448
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male