MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-14 for DIALOG A + 1 BLOOD PUMP 120V 710500K manufactured by B. Braun Avitum Ag - Melsungen.
[62336439]
(b)(4). The machine trend file and all available information has been forwarded to the manufacturer. 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
[62336440]
As reported by the user facility: customer reported the needle dislodged from the patient and the machine did not alarm. The patient was set to run on the machine for 4 hrs and at 3:15, it was discovered that the needle dislodged from the patient and was shooting blood into the coat that the patient had on. The nurses stopped the therapy after noticing something was wrong with the patient. Medical intervention was necessary. Clinicians administered normal saline solution. The patient was sent to the emergency room, had several heart attacks, and passed away two days later in the hospital. " no alarm was triggered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002879653-2016-00036 |
| MDR Report Key | 6173396 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-14 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-12-06 |
| Date Facility Aware | 2016-12-12 |
| Report Date | 2015-12-14 |
| Date Reported to FDA | 2015-12-14 |
| Date Reported to Mfgr | 2016-12-14 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2016-12-14 |
| 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 | MS IRIS RATKE |
| Manufacturer Street | BUSCHBERG 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | 34212 |
| Manufacturer Phone | 661713718 |
| Manufacturer G1 | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Street | SCHWARZENBERGER WEG 73-79 |
| Manufacturer City | MELSUNGEN, D-34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG A + 1 BLOOD PUMP 120V |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-12-14 |
| Model Number | 710500K |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN, D-34212 GM D-34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Other; 4. Required No Informationntervention | 2016-12-14 |