MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-05-16 for DIALOG A +INCL. BIC 710200C manufactured by B.braun Avitum Ag.
[75322488]
(b)(4), event #2. Inital information was received from the distributor in (b)(4). The machine trend file and additional information has been requested from the facility and the investigation is on-going at this time. A follow up report will be provided when the evaluation results are available.
Patient Sequence No: 1, Text Type: N, H10
[75322489]
Event #2: as reported by the user facility in (b)(4): ultrafiltration (uf) deviation in dialysis machine dialog+ without related alarms. The ultrafiltration was higher than programmed. The patient developed hypotension and cramps during the therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002879653-2017-00006 |
| MDR Report Key | 6569388 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-05-16 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-04-05 |
| Date Facility Aware | 2017-05-12 |
| Report Date | 2017-08-18 |
| Date Reported to FDA | 2017-08-18 |
| Date Reported to Mfgr | 2017-08-18 |
| Date Mfgr Received | 2017-04-18 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2017-05-16 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JONATHAN SEVERINO |
| Manufacturer Street | 824 10TH AVENUE |
| Manufacturer City | BETHLEHEM PA 180180027 |
| Manufacturer Country | US |
| Manufacturer Postal | 180180027 |
| Manufacturer Phone | 4847197287 |
| Manufacturer G1 | B. BRAUN AVITUM AG (REG #3002879653) |
| Manufacturer Street | SCHWARZENBERGER WEG 73-79 |
| Manufacturer City | MELSUNGEN 34212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG A +INCL. BIC |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2017-05-16 |
| Returned To Mfg | 2017-05-05 |
| Catalog Number | 710200C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN AVITUM AG |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN, 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-16 |