MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-11-10 for LIBERTY CYCLER SET, SINGLE CONN./EXT.DL 050-87216 manufactured by Fresenius Medical Care North America.
[31336791]
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. Device review: the device was not returned to the manufacturer for physical evaluation. The customer was unable to provide the manufacturer with the lot number of the product used in the reported event. As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event. The record review found 2 lot numbers shipped to the customer during that time period. The batch production records for these lots were reviewed. The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specifications. Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.
Patient Sequence No: 1, Text Type: N, H10
[31336792]
Another manufacturer reported a peritoneal dialysis (pd) patient "kept getting peritonitis" while using fresenius products. It was noted the patient switched to another manufacture's products and have not had any problems. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2015-00513 |
| MDR Report Key | 5224929 |
| Report Source | OTHER |
| Date Received | 2015-11-10 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-10-08 |
| Date Mfgr Received | 2015-10-12 |
| Date Added to Maude | 2015-11-16 |
| 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 | REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS. CP 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIBERTY CYCLER SET, SINGLE CONN./EXT.DL |
| Product Code | FKC |
| Date Received | 2015-11-10 |
| Catalog Number | 050-87216 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other | 2015-11-10 |