MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH 190618 manufactured by Concord Manufacturing.
[183820379]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[183820380]
A user facility reported to fresenius (b)(4) that a 2008k2 hemodialysis (hd) machine would not power on. There was no patient involvement at the time of this event. A fresenius (b)(4) technician was scheduled to service the reported machine. Upon arrival at the facility, the technician inspected the machine and found that power control board was burnt. He replaced the power control board and the device was able to turn on. The device alarmed with 5 volt error and 24 volt errors. The capacitors were replaced on the power supply. The interior electrical components of the device were cleaned and a functionality test was performed. The device was returned in functioning order. The technician reported that the likely cause of the malfunction was due to frequent power outages at the facility. The hd device is moved around and used in different areas of the hospital. There is no sample available to return for physical evaluation. This report was received from fresenius (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2020-00508 |
| MDR Report Key | 9845483 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2011-12-14 |
| Date Added to Maude | 2020-03-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-17 |
| Catalog Number | 190618 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-17 |