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 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Clinical review: it was stated the patient has had no pain, swelling, any issues or worsening with the hernia since being on pd.The nurse confirmed the patient did not have any adverse effects from use of fresenius device, or product.The patient is completing pd treatments with the fresenius cycler without any adverse effects.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.Therefore, the completion of a clinical investigation is not warranted at this time.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient reported developing a hernia on (b)(6) 2021 and was scheduled to have surgery.However, in additional follow-up with two pd nurse¿s familiar with the patient it was confirmed the patient had a pre-existing inguinal hernia prior to start of pd therapy on (b)(6) 2021.The nurse states the patient had postponed a hernia repair as the patient had broken his hip from a fall unrelated to dialysis on (b)(6)2021 and was in rehab until (b)(6) 2021.The patient was seen in the outpatient pd clinic on (b)(6) 2021 for routine care and the doctor reportedly set up referral for planned hernia repair now that patient has healed from a broken hip.It was stated the patient has had no pain, swelling, any issues or worsening with the hernia since being on pd.The nurse confirmed the patient did not have any adverse effects from use of fresenius device, or product.The patient is completing pd treatments with the fresenius cycler without any adverse effects.The cycler is not available to be returned for manufacturer investigation.

Event Description

A peritoneal dialysis (pd) patient reported developing a hernia on (b)(6) 2021 and was scheduled to have surgery.However, in additional follow-up with two pd nurse¿s familiar with the patient it was confirmed the patient had a pre-existing inguinal hernia prior to start of pd therapy on (b)(6) 2021.The nurse states the patient had postponed a hernia repair as the patient had broken his hip from a fall unrelated to dialysis on 18/oct/2021 and was in rehab until 15/nov/2021.The patient was seen in the outpatient pd clinic on (b)(6) 2021 for routine care and the doctor reportedly set up referral for planned hernia repair now that patient has healed from a broken hip.It was stated the patient has had no pain, swelling, any issues or worsening with the hernia since being on pd.The nurse confirmed the patient did not have any adverse effects from use of fresenius device, or product.The patient is completing pd treatments with the fresenius cycler without any adverse effects.The cycler is not available to be returned for manufacturer investigation.

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-conformance's, 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.

Manufacturer Narrative

Correction: a.2.

Event Description

A peritoneal dialysis (pd) patient reported developing a hernia on (b)(6) 2021 and was scheduled to have surgery.However, in additional follow-up with two pd nurse¿s familiar with the patient it was confirmed the patient had a pre-existing inguinal hernia prior to start of pd therapy on (b)(6) 2021.The nurse states the patient had postponed a hernia repair as the patient had broken his hip from a fall unrelated to dialysis on 18/oct/2021 and was in rehab until 15/nov/2021.The patient was seen in the outpatient pd clinic on 22/dec/2021 for routine care and the doctor reportedly set up referral for planned hernia repair now that patient has healed from a broken hip.It was stated the patient has had no pain, swelling, any issues or worsening with the hernia since being on pd.The nurse confirmed the patient did not have any adverse effects from use of fresenius device, or product.The patient is completing pd treatments with the fresenius cycler without any adverse effects.The cycler is not available to be returned for manufacturer investigation.

• 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: 13204293
• MDR Text Key: 284180288
• Report Number: 2937457-2022-00041
• 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,Followup
• Report Date: 02/28/2022

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: 12/28/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 02/09/2022; 02/28/2022
• Supplement Dates FDA Received: 02/21/2022; 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2009
• 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; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Other
• Patient Age: 77 YR