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 2016-12-29 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[63626899]
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
[63626900]
The dialysis charge nurse at the user facility reported a blood loss event that occurred approximately 2 hours after initiation of the patient's hemodialysis (hd) treatment. The charge nurse described what appeared as a negative draining sound coming from the 2008k@home hemodialysis (hd) machine. Air, present in the arterial chamber of the bloodline, reportedly traveled to the blood pump, however, no air alarm was generated by the 2008k@home hd machine. The patient? S treatment was stopped, and the extracorporeal circuit was discarded. The patient's estimated blood loss (ebl) was noted as being approximately 300ml. , the patient was re-setup on another machine, and then the treatment was continued and successfully completed without any further issues being reported. Following the event, the 2008k@home hd machine was removed from service for evaluation. Additionally, following the blood loss, the patient's hemoglobin (hgb) was noted as being low. However, no patient adverse effects were experienced and no medical intervention was required as a result of this event. The bloodline complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
Patient Sequence No: 1, Text Type: D, B5
[67889461]
Although requested, no further event related details have been received. Therefore, it is not currently known if any service related repair activities have been performed or if the unit has been returned to service at the user facility. Should additional information become available, a supplemental mdr will be submitted. The device was not returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis. 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 deviations or non-conformances during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the material and process controls were within specification. 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
[67889462]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2016-01265 |
| MDR Report Key | 6212333 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-12-29 |
| Date of Report | 2017-02-17 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2017-02-09 |
| Device Manufacturer Date | 2014-04-22 |
| Date Added to Maude | 2016-12-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | 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 | 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2016-12-29 |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| 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 | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-29 |