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

Model Number 180343

Device Problem Overfill (2404)

Patient Problems Malaise (2359); Increased Intra-Peritoneal Volume (IIPV) (4498)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report m41 patient sensor too high alarm during drain 1 of 4.The patient called technical support and reported 4700 ml had drained.The patient discontinued treatment during drain 1 of 4 due to the large drain.A review of the patient¿s cycler data during troubleshooting identified the patient drained over 6000ml during treatment.Upon follow up the pdrn reported the patient drained 3700 during the event.The initial reported drain volume is 300% the patient's prescribed fill volume of 2 l.As a result of the iipv event, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow up with the pdrn, it was reported that the patient did not feel well as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).Additional information has been requested but to date has not been provided.

Event Description

This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report m41 patient sensor too high alarm during drain 1 of 4.The patient called technical support and reported 4700 ml had drained.The patient discontinued treatment during drain 1 of 4 due to the large drain.A review of the patient¿s cycler data during troubleshooting identified the patient drained over 6000ml during treatment.Upon follow up the pdrn reported the patient drained 3700 during the event.The initial reported drain volume is 300% the patient's prescribed fill volume of 2 l.As a result of the iipv event, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow up with the pdrn, it was reported that the patient did not feel well as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).Additional information has been requested but to date has not been provided.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were visual indications of dried fluid within the cassette compartment.No particulates were observed within the cassette area.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.An as received simulated treatment was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.The cycler underwent and passed a system air leak and valve actuation test.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.During an internal inspection of the returned cycler visual indications of dried fluid were found underneath the pump.There were no other 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.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12700853
• MDR Text Key: 278616208
• Report Number: 2937457-2021-02147
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/19/2022
• Device Age: MO
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 01/29/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 66 KG