MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-05-31 for 2008K@HOME HEMODIALYSIS SYSTEM 190828 manufactured by Concord Manufacturing.
[109749359]
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
[109749360]
It was reported that a patient was having abdominal pain during their hemodialysis (hd) therapy on a fresenius 2008k@home machine and the machine began beeping. The patient pushed buttons (unknown which ones) and the machine began to alarm. The patient tried to manually pump the blood back but was too weak to do so due to having the flu. The patient? S estimated blood loss was 100 ml. There was no patient injury or medical intervention required as a result of the reported event. The blood loss was attributed to the patient? S inability to manually pump the blood back and not related to a machine malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-01514 |
| MDR Report Key | 7558725 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-31 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2018-05-31 |
| 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 |
| 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 HEMODIALYSIS SYSTEM |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-05-31 |
| Catalog Number | 190828 |
| Operator | LAY USER/PATIENT |
| 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 | 2018-05-31 |