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 Problems Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 08/22/2021

Event Type  Injury  

Manufacturer Narrative

Clinical statement: based on the limited available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient requested assistance disconnecting from the cycler during fill 6 of 6 of treatment to go to the hospital.Technical support assisted the patient with cancelling treatment.Subsequent attempts to obtain additional information (e.G., discharge summary, hospital records, treatment data) have thus far proven unsuccessful.Based on the limited available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.

Manufacturer Narrative

Additional information: b5, g2, h6 clinical code, h10 clinical statement clinical statement: based on the available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.

Event Description

It was reported that a peritoneal dialysis (pd) patient requested assistance disconnecting from the cycler during fill 6 of 6 of treatment to go to the hospital.Technical support assisted the patient with cancelling treatment.Upon follow-up, the patient¿s pd registered nurse (pdrn) revealed the patient was feeling unwell due to a urinary tract infection (uti).Although the patient was hospitalized, the pdrn reported the events were unrelated to pd therapy.Based on the available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further 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-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

It was reported that a peritoneal dialysis (pd) patient requested assistance disconnecting from the cycler during fill 6 of 6 of treatment to go to the hospital.Technical support assisted the patient with cancelling treatment.Upon follow-up, the patient¿s pd registered nurse (pdrn) revealed the patient was feeling unwell due to a urinary tract infection (uti).Although the patient was hospitalized, the pdrn reported the events were unrelated to pd therapy.Based on the available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further investigation.

Manufacturer Narrative

Additional information: d9, g1, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated with reduced dwell times and completed on the cycler without complication.The cycler underwent system air leak, teach pump, and valve actuation testing and was found to meet product specifications.There were no visual discrepancies encountered during the internal inspection.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

Event Description

It was reported that a peritoneal dialysis (pd) patient requested assistance disconnecting from the cycler during fill 6 of 6 of treatment to go to the hospital.Technical support assisted the patient with cancelling treatment.Upon follow-up, the patient¿s pd registered nurse (pdrn) revealed the patient was feeling unwell due to a urinary tract infection (uti).Although the patient was hospitalized, the pdrn reported the events were unrelated to pd therapy.Based on the available information, there is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) occurred warranting further 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: 12388206
• MDR Text Key: 268977201
• Report Number: 2937457-2021-01815
• 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,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Device Age: MO
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• 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; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization