MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.
[185528437]
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the patient? S adverse events of pulmonary edema, nstemi (characterized by dyspnea and chest pain) and subsequent expiration. Although the patient expired while connected to the liberty select cycler, the patient elected to enter hospice care prior to undergoing pd therapy (comfort measures for improved oxygenation. Per the pdrn, the events were unrelated to the patient? S utilization of the liberty select cycler or any fresenius product(s) or device(s). Additionally, hospice care is defined as a medical intervention, with the expected outcome being the patient will expire as a result. Therefore, based on the totality of the information available, the liberty select cycler can be disassociated from the events. There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction was associated with the patient? S expiration. The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. 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
[185528438]
It was reported that a patient on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) expired the morning of (b)(6) 2020 while connected to a liberty cycler. Additionally, the patient was reportedly being tested for covid-19 prior to their passing. During follow-up, the patient? S registered nurse (rn) reported the patient was hospitalized (admission date not provided) for suspicion of covid-19, pulmonary edema and non-st elevation myocardial infarction (nstemi), characterized by shortness of breath (dyspnea) and chest pain. The patient was housed in the intensive care unit (icu) due to their instability. The patient was becoming increasingly dyspneic and after discussions with their doctor and family, the patient elected to be transitioned to? Comfort measures only? (hospice). The patient declined intubation, signed a dnr/dni form, and understood the ramifications of their decision. The rn stated the patient was receiving three vasopressors (drug, dosage not provided) for blood pressure support prior to initiating pd therapy. The patient? S pre-treatment vitals were blood pressure (supine) = 90/55, heart rate = 102, temperature = 97. 7, respirations = 26. The nephrologist ordered pd therapy to remove additional fluid to potentially improve the patient? S oxygenation. The patient? S ccpd treatment was initiated at 21:45 and remained uneventful until the patient expired at 00:23 on (b)(6) 2020. The rn stated the liberty cycler did not malfunction, nor was there any concern a fresenius product or device caused or contributed to the patient? S death. The cycler was retained by the inpatient dialysis staff for continued use. The patient? S test results for covid-19 were negative. The rn stated they had no access to the patient? S death certificate, esrd death notification, discharge summary, patient demographics or outpatient home dialysis clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00557 |
| MDR Report Key | 9897959 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2018-11-20 |
| 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 | 0 |
| 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 | HEALTH PROFESSIONAL |
| 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. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-30 |