MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-08 for LIBERTY CYCLER SET UNKNOWN- FMC CASSETTE manufactured by Erika De Reynosa, S.a. De C.v..
[85439275]
The device has not been returned to the manufacturer. A supplemental report will be filed upon completion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[85439276]
A peritoneal dialysis patient reported that the cycler displayed a drain complication and was unable to bypass. The patient set up with new supplies. During a follow up phone call to the patient's nurse, it was reported that the patient got peritonitis on (b)(6) 2017 and was given a 14 day treatment of fortaz in his solution. The culture was taken and the results showed (acinetobacter baumannii). The patient was able to complete treatment the time of the call after contacting the rn. She assisted the patient with completing with medicated solution without further issues. The patient is still recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2017-00666 |
| MDR Report Key | 6852797 |
| Report Source | CONSUMER |
| Date Received | 2017-09-08 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-09-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY CYCLER SET |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKC |
| Date Received | 2017-09-08 |
| Catalog Number | UNKNOWN- FMC CASSETTE |
| 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 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-08 |