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 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.
[185917605]
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 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: no parts were returned to the manufacturer for physical evaluation. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Patient Sequence No: 1, Text Type: N, H10
[185917606]
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 | 2937457-2020-00551 |
| MDR Report Key | 9891685 |
| 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 | 2020-03-31 |
| Device Manufacturer Date | 2019-07-22 |
| 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 | CONCORD MANUFACTURING |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) |
| Generic Name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Product Code | FKX |
| Date Received | 2020-03-27 |
| Model Number | 180343 |
| Catalog Number | RTLR180343 |
| 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 | CONCORD MANUFACTURING |
| Manufacturer Address | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |