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 2017-05-03 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[74366113]
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
[74366114]
A home hemodialysis (hhd) patient reported to a fresenius medical care (b)(4) (fmcc) regional service representative (rsr) that the 2008k@home hd machine was running with the blood pump and ultrafiltration (uf) pump turned off which resulted in approximately 100 milliliters (ml) of blood loss. The patient reportedly experienced a headache and discomfort while undergoing their hd treatment. The patient "pushed a few buttons" and then continued with the hd therapy. The patient was unable to recall which buttons were pushed. After an undetermined amount of time, the patient realized that the blood pump and uf pump were no longer running. The patient alleged that there were no audible or visual alarms generated by the machine to alert the user of the pump stoppage. The patient did not observe clotted blood within the extracorporeal circuit, but due to concerns related to the length of time the pumps were stopped, the patient did not return all of the blood within the lines. The estimated blood loss (ebl) was noted as being approximately 100 ml. No patient adverse effects were experienced and no medical intervention was required as a result of this event. Following the event, the rsr performed a machine evaluation. The rsr performed a simulated treatment which showed that the machine alarmed to specification when the blood pump was stopped in an emergency mode or the uf was turned off for more than 10 minutes at a time. Functional testing performed by the rsr confirmed that the system was operating properly; system functioned within specification. No parts were replaced and the system was cleared for use. The patient has been able to continue their regularly scheduled hd treatments using this machine.
Patient Sequence No: 1, Text Type: D, B5
[96765873]
Plant investigation: no parts were returned to the manufacturer for physical evaluation. On-site evaluation of the unit was performed by a fresenius medical care canada (fmcc) regional service representative (rsr) following the event. Functional testing performed by the rsr confirmed that the system was operating properly and functioned within specification. No parts were replaced and the system was cleared for use. The patient has been able to continue their regularly scheduled hd treatments using this machine. 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 non-conformances or any associated rework during the manufacturing process which could be associated with the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The investigation into the cause of the reported problem was not able to be confirmed. The rsr performed functional testing which revealed that the device functioned fully as designed and within specification. Therefore, the complaint has been deemed not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[96765874]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-00317 |
| MDR Report Key | 6540222 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-05-03 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-04-08 |
| Date Mfgr Received | 2017-05-25 |
| Device Manufacturer Date | 2012-06-11 |
| Date Added to Maude | 2017-05-03 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2017-05-03 |
| Model Number | 2008K@HOME |
| Catalog Number | 190395 |
| ID Number | 00840861100958 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-05-03 |