MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-30 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.
[186519557]
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient? S adverse events of hernia, characterized by abdominal pain and discomfort, which warranted a decrease in fill volume. The exact etiology of the unspecified hernia is unknown; therefore, causality cannot be established. While there is no direct allegation or objective evidence indicating a liberty select cycler deficiency or malfunction caused or contributed to the events. There is insufficient evidence to exclude the liberty select cycler from having a possible causal or contributory role in the creation or exacerbation of the hernia. Hernias are a well-known potential complication of pd therapy due to increased intra-abdominal pressure created during pd therapy. During therapy, this pressure can create or exacerbate weaknesses in the supporting abdominal wall structures. Additionally, the surgical introduction of the pd catheter (not a fresenius product) also increases the risk of hernia formation. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[186519558]
It was reported that a patient on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was diagnosed with a hernia (type/specifics not provided). The patient reported their peritoneal dialysis registered nurse (pdrn) advised them to fill with 900-1000 ml during the first fill, to avoid causing too much pain. During follow-up, the pdrn stated the patient? S hernia was not a preexisting condition. Approximately 2 weeks ago the patient presented to the outpatient home therapy clinic with drain complications, abdominal pain and discomfort. The patient was sent to the? Access clinic? And radiological testing (specifics not provided) revealed a hernia (type not provided). The nephrologist ordered a decrease in the patient? S fill volume to 900-1000 ml per, resulting in relief from the pain and discomfort. Surgery has been placed on-hold, and the access clinic will continue to monitor the hernia for changes. The etiology of the hernia is unknown, and the pdrn is unaware of any events which may have caused or contributed to its formation. The pdrn stated the patient continues to undergo ccpd at home utilizing the same liberty select cycler without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00558 |
| MDR Report Key | 9898044 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-11-13 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Model Number | 180343 |
| Catalog Number | RTLR180343 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |