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 2017-11-06 for 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG 190904 manufactured by Concord Manufacturing.
[92212451]
A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[92212452]
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient reported during recirculation mode the saline bag was visibly seen backfilling with solution. The biomed tech stated he went to the patient? S home to examine the machine and performed machine checks and could not duplicate the issue and no issues were determined. Per biomed tech the machine passed all functional checks (fc) and the patient was able to continue on with hemodialysis treatment without issue. The biomed tech stated the machine did have the cbe upgraded before the saline bag backfilled and prior to the incident but was unable to provide an exact date. No repairs were needed. The biomed tech declined any res services and stated the machine remained in use without further issue. No parts were available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2017-01144 |
| MDR Report Key | 7004627 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-06 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-11-06 |
| 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 | 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 W/ BIBAG |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2017-11-06 |
| Catalog Number | 190904 |
| 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 | 2017-11-06 |