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 2020-03-27 for FMC CASSETTE UNKNOWN- FMC CASSETTE manufactured by Erika De Reynosa, S.a. De C.v..
[188389057]
Clinical investigation: a temporal relationship exists between the pd therapy with the liberty select cycler/fmc cassette and the patient? S peritonitis event. However, there is no objective evidence that a liberty select cycler/ fmc cassette malfunction or product deficiency was associated with this event. The exact cause of the patient? S peritonitis cannot be determined. The patient? S pd culture yielded growth of klebsiella oxytoca which is an organism that is commonly found in the intestinal tract and stool of humans. The patient? S nurse reported the patient had concomitant clostridium difficile infection and the patient? S nephrologist suspected the peritonitis infection was associated to transmural infection from the gut. Other potential sources for the patient? S peritonitis may include a breach in aseptic technique, the patient? S pd catheter (not a fresenius product) or the patient placing the drain line too low in the toilet, as also reported by the patient? S nurse. However, the liberty select cycler owner? S manual cautions the user not to submerge the drain lines into fluid such as toilet bowl. Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided. A manufacturing review was performed on the lots of products shipped to the patient for the three (3) month time frame prior to the event occurrence date. The entire set of lots have been sold and distributed. There were no non-conformances or abnormalities identified during the manufacturing process associated with the reported event. An investigation of the device history records was conducted and confirmed that the results of the in-progress and final quality control testing met all requirements. The product lots involved met all specifications for release. 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
[188389058]
It was reported that a peritoneal dialysis (pd) patient was hospitalized for peritonitis on (b)(6) 2020. Upon follow-up, the pd registered nurse (pdrn) reported that the patient was experiencing abdominal pain and first entered the hospital on (b)(6) 2020. A pd culture obtained on the same date yielded growth of klebsiella oxytoca. The patient was subsequently admitted (b)(6) 2020. The patient was treated with intravenous (iv) gentamycin. Additionally, the patient underwent pd catheter removal (not a fresenius product) on approximately (b)(6) 2020 and remained on hemodialysis while hospitalized. The patient was discharged from the hospital on (b)(6) 2020 and was reportedly recovering from the peritonitis event. The nurse confirmed there were no fluid leaks, malfunctions, nor deficiencies with any fresenius products which may have attributed to this event. Per the nurse, the cause of the patient? S peritonitis is unknown, however, there were several potential contributing factors. Reportedly, the patient? S pd catheter may have been a potential source of infection as the patient was experiencing issues draining. The nurse suspects the patient? S depression and alcohol use may have led to a breach in aseptic technique. Another source of possible infection may have been from placing the drain line in the toilet. During the last follow-up the nurse indicated the patient had concomitant clostridium difficile infection while hospitalized. According to the nurse, the patient? S nephrologist believes the peritonitis is associated to transmural infection from the gut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00366 |
| MDR Report Key | 9891692 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2020-03-27 |
| 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 | FMC CASSETTE |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-27 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |