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 Hypoxia (1918); Pneumonia (2011)

Event Date 07/03/2023

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing a liberty select cycler, and the serious adverse event of death, as the patient was undergoing ccpd therapy when the serious adverse event occurred.Per the patient¿s caregiver, the patient was discharged from the hospital (pneumonia/hypoxia) and expired the same evening.Although the primary cause of death is unknown, the patient¿s caregiver reported the cause of death was unrelated to the patient¿s utilization of a fresenius device(s) and/or product(s).It should be noted that an inability to obtain follow-up information precluded a more comprehensive investigation.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Based on the information available, the liberty select cycler can be disassociated from this serious adverse event.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report a fresenius product(s) and/or device(s) failed to meet user expectations or manufacturer specifications.

Event Description

On (b)(6) 2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to hypoxia and pneumonia (admission date not provided).The patient¿s caregiver reported the patient was discharged on (b)(6) 2023 (approximately 2:30 pm) and expired later the same evening while undergoing ccpd therapy (dwell 1 of 5).During intake, the patient¿s caregiver reported the patient¿s expiration was unrelated to her utilization of a fresenius device(s) and/or product(s).Subsequent attempts to obtain additional information regarding the reported hospitalization and serious adverse events (e.G., death certificate, esrd death notification, discharge summary) were unsuccessful.

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

On (b)(6) 2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to hypoxia and pneumonia (admission date not provided).The patient¿s caregiver reported the patient was discharged on (b)(6) 2023 (approximately 2:30 pm) and expired later the same evening while undergoing ccpd therapy (dwell 1 of 5).During intake, the patient¿s caregiver reported the patient¿s expiration was unrelated to her utilization of a fresenius device(s) and/or product(s).Subsequent attempts to obtain additional information regarding the reported hospitalization and serious adverse events (e.G., death certificate, esrd death notification, discharge summary) were unsuccessful.

Manufacturer Narrative

Additional information provided in d9 and h3.Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.The cycler underwent and passed a system air leak test and valve actuation test.An (as received) simulated treatment was performed and completed.The cycler weighed fill volume values were within tolerance for a liberty cycler.There were no visual discrepancies found 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

On 4/jul/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to hypoxia and pneumonia (admission date not provided).The patient¿s caregiver reported the patient was discharged on (b)(6) 2023 (approximately 2:30 pm) and expired later the same evening while undergoing ccpd therapy (dwell 1 of 5).During intake, the patient¿s caregiver reported the patient¿s expiration was unrelated to her utilization of a fresenius device(s) and/or product(s).Subsequent attempts to obtain additional information regarding the reported hospitalization and serious adverse events (e.G., death certificate, esrd death notification, discharge summary) were unsuccessful.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17332854
• MDR Text Key: 319129071
• Report Number: 0002937457-2023-01021
• 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: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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
• Device Age: MO
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2008
• 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): Death
• Patient Sex: Female