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

Catalog Number RTLR180343

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Overfill (2404)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between the patient event of fluid volume overload with hypertension and subsequent hospitalization and pd therapy on the liberty select cycler.There is a possible causal relationship between the fluid volume overload and hypertension and the reported inability of the patient to not being able to complete therapy on the liberty select cycler due to display distortions and difficulty to load the cassette.An investigation has not been completed on the machine as of this date.It is unknown if the patient utilized manual exchanges, however, the patient also had a malfunction of the pd catheter (not a fresenius product) which most likely contributed to the fluid overload.The patient¿s chronic hypertension was exacerbated by incomplete dialysis treatments and the patient¿s non-compliance to medication.Based on the available information, the liberty select cycler cannot be ruled out as causing or contributing to the patient adverse event.

Event Description

On (b)(6) 2018 a contact for this patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for a replacement cycler.The current liberty select cycler was delivered on (b)(6) 2018 and they were unable to load the cassette and the display was distorted.The patient was currently in the hospital related to pd therapy.Per the contact, the patient was unable to complete one treatment on the current liberty select cycler.Additional information was obtained through follow up on (b)(6) 2018 with the peritoneal dialysis registered nurse (pdrn).Per the pdrn, the patient was admitted to the hospital on (b)(6) 2018 for fluid volume overload (unknown volume) and hypertension (unknown value) as the patient was not able to complete treatment on the liberty select cycler.It is unknown if the patient utilized manual exchanges during the four days prior to hospitalization.During the hospitalization it was determined that the patient¿s pd catheter (not a fresenius product) had malfunctioned (unspecified) and a perm catheter was placed.The patient transitioned to hemodialysis (hd) until the pd catheter could be revised.The fluid overload resolved after hd treatment.The patient has chronic hypertension and is non-compliant with hypertensive medications.Further hospital course is unknown.The patient was discharged on (b)(6) 2018 on in-center hd until the physician schedules a revision of the pd catheter.

Manufacturer Narrative

Additional information: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: removed device code c62884 - overfill.Added device codes c63088 and c63221.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.The cassette/door switch check passed.The force gauge test passed.The safety clamp operation check passed.The system air leak test passed.A pre-accelerated stress test 15 min 1000 ml simulated treatment (self test) was performed and completed with no problems or failures.There were no 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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8217709
• MDR Text Key: 132092076
• Report Number: 2937457-2019-00052
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Device Age: MO
• Date Manufacturer Received: 03/26/2019
• 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
• Patient Age: 58 YR