MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2015-12-29 for LIBERTY CYCLER SET, SINGLE CONN. / EXT. DL 050-87216 manufactured by Fresenius Medical Care North America.
[35009773]
This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[35009774]
A peritoneal dialysis (pd) patient initially reported trouble draining and a recent hospital discharge. During follow up with patient's peritoneal dialysis registered nurse (pdrn), it was learned the patient was hospitalized from (b)(6) 2015 for no-growth peritonitis, per pdrn, the patient received a 14 day course of unknown antibiotics and is recovering. The pdrn stated there had been no break in aseptic techniques or compromise of sterile pathway prior to diagnosis of peritonitis.
Patient Sequence No: 1, Text Type: D, B5
[41353925]
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. The complaint device lot number was not reported, however the sales and shipping records for the patient were reviewed for three months prior to the date of occurrence. No product was available from these lots in distribution centers to be analyzed, as the entirety of the lots have been sold and distributed. Device history review was performed on the potential related lots. No non-conformance reports or other abnormalities during the manufacturing process were found for these lots. The product involved met current specifications. In addition, the device record review confirmed the labeling, material, and process controls were within specification. The system level review of cycler device and concomitant products found no indication that the products caused or contributed in any way to the clinical event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2015-00612 |
| MDR Report Key | 5340401 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2015-12-29 |
| Date of Report | 2016-03-28 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-04 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TANYA TAFT, RN CNOR |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 024511457 |
| Manufacturer Country | US |
| Manufacturer Postal | 024511457 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKE DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS, CP88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY CYCLER SET, SINGLE CONN. / EXT. DL |
| Product Code | FKC |
| Date Received | 2015-12-29 |
| Catalog Number | 050-87216 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | REYNOSA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-12-29 |