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

Model Number LIBERTY SELECT CYCLER

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Peritoneal dialysis patient reported to technical support of not feeling well and vomiting during peritoneal dialysis treatment.Patient was advised to cancel treatment and to contact the clinic nurse.Follow up with the patient¿s peritoneal dialysis nurse indicated that the patient was hospitalized (date unknown) for ileus.Additional information was solicited.

Event Description

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Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

Additional information was solicited and received.The patient (pt.) presented to the emergency room (er) and was admitted to the hospital with complaints of nausea, vomiting, and abdominal pain.The pt.Also made report that he experienced sudden onset of lumbar back pain radiating to both flanks while infusing (pd) dialysate the night prior to hospitalization.A computerized tomography (ct) scan of the pt¿s abdomen and pelvis indicated multiple dilated loops of small bowel concerning for ileus versus small bowel obstruction (sbo).The pt.Required placement of a nasogastric tube (ngt) placement with low continuous wall suction (lcws) and nothing by mouth (npo) initially.However, on hospital day 1 it was recorded the pt.Was able to pass flatus and tolerated clear liquid diet which resulted in removal of the ngt.The pt.Subsequently advanced to regular diet without further abdominal pain, nausea or vomiting.It was recorded, the pt¿s abdominal etiology was most likely related to an ileus.Furthermore, the pt.Continued pd therapy during hospitalization (treatment and product details unknown) without any indication of a pd associated event.On (b)(6) 2018, the pt¿s vital signs recorded blood pressure (bp) 149/87, pulse 77, temperature (oral) 98.2 f, respiratory rate (rr) 20, oxygen saturation 99%, weight 71.2kg and the pt.Was deemed stable for discharge home continuing on pd therapy with his home cycler.

Manufacturer Narrative

While there is a temporal relationship between ccpd treatment with the liberty select cycler and the pt¿s abdominal pain warranting hospital admission; there is no documentation that supports a causal relationship.The pt.Was diagnosed with an ileus during hospitalization which was most likely associated with the pt¿s abdominal pain.While it is unknown what may have caused the pt.To develop an ileus; there is no objective evidence that reasonably suggests the liberty select cycler was associated in anyway with the pt¿s ileus event.

• 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: 7483982
• MDR Text Key: 107257020
• Report Number: 2937457-2018-01222
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 71