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

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144); Weakness (2145); Hypovolemia (2243)

Event Date 07/19/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s hospitalization for hypotension, hypovolemia, nausea, vomiting, cystitis, severe protein-calorie malnutrition and anemia.The document indicates the cause of the patient¿s hypotension was hypovolemia, due to a combination of severe protein-calorie malnutrition , nausea, vomiting and cystitis.The patient¿s anemia is considered a chronic problem and will be managed outpatient.Per the pdrn, events are considered to be resolving, and are unrelated to any fresenius product(s).Based on the totality of the information available, the liberty select cycler can be disassociated from the event, as there is no allegation or objective evidence indicating a liberty select cycler product deficiency or malfunction caused or contributed to the event(s).Furthermore, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.Should additional information become available, please resubmit for a clinical review and the clinical investigation will be updated accordingly.

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized from (b)(6) 2019 through (b)(6) 2019 due to hypotension.Upon examination of the discharge summary, the patient was found to be hypotensive due to hypovolemia from reduced intake, generalized weakness and cystitis.It was indicated that the patient had been feeling unwell for the past month with recurrent nausea, vomiting, and dry heaves during dialysis exchange.The patient received hydration and treated with antibiotics for an unrelated urinary tract infection.The patient underwent a chest x-ray and there were no findings.There was no evidence of blood loss or peritonitis.Nephrology was consulted to review her pd prescription and adjust as needed.Although the precise changes made were not provided, the alteration in pd prescription was successful in relieving the patient¿s nausea, vomiting and dry heaves.

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.

Manufacturer Narrative

Corrected information: product problem and patient codes.

• 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: 8891900
• MDR Text Key: 154245352
• Report Number: 2937457-2019-02565
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/19/2019
• 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: 76 YR
• Patient Weight: 77