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

Catalog Number RTLR180111

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Congestive Heart Failure (1783); Dyspnea (1816); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

There is a temporal relationship with pd therapy on the liberty cycler and the patient event of dyspnea, abdominal pain with subsequent hospitalization and diagnosis of fluid overload, sirs, pulmonary edema and congestive heart failure.Per the patient and the pdrn the liberty cycler was not operating properly for a week prior to the patient¿s hospitalization which led the patient to not complete pd treatments.The patient did not specify the issues with the cycler and did not contact technical support or their pdrn to report the issues therefore there is no documentation that shows any issues the patient was experiencing with the cycler.The machine evaluation has not been completed at the time of this clinical evaluation.Based on the available information a cause for the fluid volume overload cannot be established.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support to report lz14 - operation questions with the liberty cycler during treatment.The pdrn (nurse) called for a replacement cycler.The pdrn stated that the cycler was not working as it should and the patient was not able to do treatment for a week.The nurse was not near the cycler at the time of the call and did not have any further information to provide.No troubleshooting was done at the time of the call.Replaced cycler due to operational question.The patient was advised to discontinue use of this cycler.Alternate treatment option is manuals.Advised to retain iq drive, no modem.The serial number was verified through sap and software version is unavailable.The fresenius technical support representative issued a replacement cycler and advised the patient to discontinue using the machine.There was no patient harm or adverse event, and no medical intervention was required.

Event Description

A peritoneal dialysis registered nurse (pdrn) for a patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support to request a replacement cycler.Per the pdrn, the patient was unable to complete treatment for a week.Additional information was obtained through follow up with the pdrn and through medical records received.The patient presented to the emergency room (er) with shortness of breath and abdominal pain due to issues with their liberty cycler over the past week (unspecified).The pdrn stated the patient did not complete any dialysis during that week.The patient was said to be nauseous with some vomiting and no bowel movement for a week.The patient was found to be significant for fluid overload.The patient¿s chest x-ray showed pulmonary edema and was found to be in congestive heart failure.The lab results for bun were 99 and creatinine was 19.33 (unknown units).The patient had a central line placed due to inability to gain peripheral intravenous (iv) access.The patient was also found to have systemic inflammatory response syndrome (sirs) due to respiratory distress.The patient was tachypneic in the er with leukocytosis (13.55 unknown units).The patient was started on iv azithromycin and ceftriaxone (dose, frequency and duration unknown).Blood cultures were drawn; however, the medical records did not record the results.The patient had a high anion gap metabolic acidosis most likely due to the kidney failure.The patient was admitted to the hospital and scheduled for dialysis.There is no documentation of treatment received during the hospitalization.The patient was discharged on six days later and has since recovered.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: concomitant medical products, device evaluated by mfr.Correction: mfr site, report source: plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler and found red marks on the heater tray and a missing serial number sticker.The molded clamp pad was missing inside the cassette compartment.There were no indications of dried fluid present within the cassette compartment, and no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.There were scratches on the front panel display surface and the heater tray was bent on the left edge.A simulated treatment was performed on the cycler and completed without failure.The cycler underwent and passed a system air leak test and valve actuation test.The load cell verification was within tolerance.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested positive for glucose.An internal visual inspection identified evidence of dried fluid on the base plate of the cycler.The cause of the dried fluid could not be determined.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.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8143099
• MDR Text Key: 129649737
• Report Number: 2937457-2018-03616
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Device Age: MO
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 59