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 2018-07-24 for HOME HEMO COMBI SET FOR CANADA 03-2932-6 manufactured by Erika De Reynosa, S.a. De C.v..
[114801018]
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
[114801019]
A fresenius representative reported a home hemo combi set bloodline kit that caused a blood loss of 150ml during patient treatment. Due diligence attempts were exhausted, but no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2018-01113 |
| MDR Report Key | 7713326 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-07-24 |
| 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 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME HEMO COMBI SET FOR CANADA |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-07-24 |
| Model Number | 03-2932-6 |
| Catalog Number | 03-2932-6 |
| Lot Number | 17KR01318 |
| 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 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |