MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2014-07-24 for FREEDOM CYCLER, FREEDOM 5-LEAD PEDIATRIC CYCLER SET manufactured by Fresenius Medical Care North America.
[17626807]
During a call to technical service regarding an alarm issue regarding the cycler, it was indicated by the patient's mother that the patient had been admitted to the hospital due to an episode of peritonitis. The clinical manager stated the patient was previously admitted to the hospital for peritonitis, was discharged and is currently completing treatments using the new cycler without issue. The following was based on medical records provided by the patient's treatment facility. The patient was admitted to the hospital on (b)(6) 2014 through (b)(6) 2014 after his mother reported a one day history of cloudy, purulent effluent peritoneal dialysis (pd) fluid. The patient was also previously hospitalized on (b)(6) 2014 through (b)(6) 2014 due to bacterial and fungal peritonitis and the concern with this admission was for an atypical candida species resistant to fluconazole had formed a biofilm within his catheter. The patient has had intermittent diarrhea and emesis as well.
Patient Sequence No: 1, Text Type: D, B5
[17811839]
The patient was admitted to the hospital on (b)(6) 2014 through (b)(6) 2014 after his mother reported a one day history of cloudy, purulent effluent peritoneal dialysis (pd) fluid. The patient was hospitalized on (b)(6) 2014 through (b)(6) 2014 due to bacterial and fungal peritonitis. During this time, he completed a 14 day course of cefepime and fluconazole intra-peritoneally (ip) through his dialysate. On (b)(6) 2014 his effluent pd fluid cultures were positive for enterobacter cloacae and klebsiella pneumoniae. On (b)(6) 2014 and (b)(6) 2014, pd fluid cultures were positive. The following was based on medical records provided by the patient's treatment facility. He completed a 14 day course of cefepime and fluconazole intraperitoneally (ip). The patient has a history of emesis which has worsened recently as well as baseline loose and frequent stools. The patient was negative for fever and chills. The patient's abdomen was non-tender with no rebound tenderness or guarding. There were normal bowel sounds. His gastrostomy tube site was clean and dry and his pd catheter showed no signs of inflammation. The patient received his last dose of fluconazole in his pd fluid on (b)(6) 2014 and did not start his fluconazole via his gastrostomy tube until (b)(6) 2014. The patient's last positive fungal culture in the pd fluid was on (b)(6) 2014 growing candida famata. His last positive bacterial culture of the pd fluid was on (b)(6) 2014. A supplemental report will be submitted upon completion of the plant's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2014-00575 |
| MDR Report Key | 4016921 |
| Report Source | 04,05,06 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-06-14 |
| Date of Event | 2014-05-16 |
| Date Mfgr Received | 2014-06-14 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-08-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TANYA TAFT, RN, CNOR |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN 1331 PARQUE INDUSTRIAL REYNOSA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CYCLER, FREEDOM 5-LEAD PEDIATRIC CYCLER SET |
| Product Code | KPF |
| Date Received | 2014-07-24 |
| Lot Number | 13BR08880 |
| Device Expiration Date | 2016-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2014-07-24 |