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 CYCLER SET, DUAL PATIENT CONNECT 050-87212 manufactured by Erika De Reynosa, S.a. De C.v..
[185919523]
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided. A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date. This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame. The entire set of lots have been sold and distributed. There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event. An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The product lots involved met all specifications for release. A review of the dhr did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[185919524]
A peritoneal dialysis (pd) patient reported they had peritonitis. During follow-up, the patient? S pd nurses reported the patient was experiencing symptoms of cloudy pd effluent. As a result, the patient was seen in the outpatient pd clinic on (b)(6) 2020 and a pd culture was obtained. The pd culture yielded growth of citrobacter bacteria. The patient was being treated on an outpatient basis with intraperitoneal (ip) antibiotics, vancomycin and ceftazidime. Per the nurse, the patient is recovering from the event and continues pd therapy without further reported issue. Per the nurses, the patient did not have any fluid leaks, or any product related issues that caused the peritonitis event. It was indicated the patient had concomitant diarrhea which is suspected to have been associated with the peritonitis. Additionally, it was reported the patient? S nephrologist attributes the peritonitis to gastrointestinal or urinary tract source via cross contamination or transmural infection. The patient? S pd nurse suspected the event most likely occurred through touch contamination. Clinical investigation: a temporal relationship exists between the pd therapy with the liberty select cycler/liberty cycler set and the patient? S peritonitis event. However, there is no objective evidence that a liberty select cycler/ liberty cycler set malfunction or product deficiency was associated with this event. The patient? S pd culture yielded growth of citrobacter bacteria which is an organism that colonizes the intestinal tract of humans and has been associated with peritonitis through abnormal bowel habits. Additionally, the bacteria is associated with associated with urinary tract infection. The patient had concomitant diarrhea which is a significant risk factor in this case of peritonitis. Additionally, it was reported the patient? S nephrologist suspected the peritonitis infection was associated with a gastrointestinal or urinary tract source via cross contamination or transmural infection. While the exact mechanism for infection cannot be clearly identified, it is reasonable to associate this event to patient comorbid conditions and/or possible cross contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00374 |
| MDR Report Key | 9900613 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-16 |
| 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 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C |
| Manufacturer City | PHARR TX 78577 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY CYCLER SET, DUAL PATIENT CONNECT |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-30 |
| Model Number | 050-87212 |
| Catalog Number | 050-87212 |
| 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 | 2020-03-30 |