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

Model Number 180343

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 03/08/2021

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 continuous cyclic pd (ccpd) therapy utilizing the liberty select cycler, and the serious adverse events of a head laceration, which required medical attention (stitches).The patient contact reportedly incurred the laceration while attempting to close the patient¿s liberty select cycler¿s cassette door.Per the pdrn, the events occurred during set-up and the patient was not connected to the device.Based on the information available, the liberty select cycler cannot be excluded from having a causal or contributory role in the events.There is currently no objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to the events.However, given the contact's allegation, the confirmation of injury and a pending manufacturer evaluation of the suspect device, the liberty select cycler cannot be disassociated from the events.

Event Description

A peritoneal dialysis (pd) patient¿s contact reported to fresenius technical support (ts) that they were experiencing difficulties closing the cassette door of the liberty select cycler in step 1 of setup.The contact reported that the cassette door closes properly without the cassette inside of it.The night prior, the contact stated that they were struck in the head by the cassette door while attempting to close it and had to go to the doctor.The ts representative issued the patient a replacement cycler.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the contact had trouble closing the cassette door and was struck on the head by the cassette door.Per the pdrn, the contact received three stitches for the laceration.The pdrn was uncertain if they had since been removed.The pdrn reported the contact was not admitted following the event, and they were sent home after receiving the stitches.The pdrn confirmed the patient received the replacement liberty select cycler and is continuing pd therapy with no further issues.The suspect cycler was returned to the manufacturer for evaluation.The pdrn confirmed the patient did not miss any treatments due to the reported issue, and they have not experienced any adverse events.

Manufacturer Narrative

Additional information: b1, d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection identified signs of physical damage on the top catch post latch.There were visual indications of dried fluid found on the top cover, however, there were no burrs or sharp edges in the cassette area that could have punctured a cassette membrane.An (as-received) 12,000 ml treatment-based continuous cyclic peritoneal dialysis simulated treatment was performed on the cycler and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.There were no fluid leaks in the test cassette during the treatment test.The cycler underwent and passed a system air leak test, a valve actuation test, and a mushroom head check.The pump door force gauge test failed due to damage on the upper door latch.An internal visual inspection identified evidence of dried fluid on the bottom cover under the pump.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.The reported complaint was confirmed as the pump door force gauge test failed due to damage that was found on the upper door latch.

Event Description

A peritoneal dialysis (pd) patient¿s contact reported to fresenius technical support (ts) that they were experiencing difficulties closing the cassette door of the liberty select cycler in step 1 of setup.The contact reported that the cassette door closes properly without the cassette inside of it.The night prior, the contact stated that they were struck in the head by the cassette door while attempting to close it and had to go to the doctor.The ts representative issued the patient a replacement cycler.Follow-up with the patient¿s pd registered nurse (pdrn) confirmed the contact had trouble closing the cassette door and was struck on the head by the cassette door.Per the pdrn, the contact received three stitches for the laceration.The pdrn was uncertain if they had since been removed.The pdrn reported the contact was not admitted following the event, and they were sent home after receiving the stitches.The pdrn confirmed the patient received the replacement liberty select cycler and is continuing pd therapy with no further issues.The suspect cycler was returned to the manufacturer for evaluation.The pdrn confirmed the patient did not miss any treatments due to the reported issue, and they have not experienced any adverse events.

• 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
• MDR Report Key: 11586942
• MDR Text Key: 242905117
• Report Number: 2937457-2021-00537
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• 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: 03/17/2021
• Device Age: MO
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention