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 2017-11-24 for HOME HEMO COMBI SET FOR CANADA 03-2932-6 manufactured by Erika De Reynosa, S.a. De C.v..
[93572693]
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[93572694]
A home hemodialysis (hd) patient reported to have experienced a kink in the arterial bloodline during hd treatment causing the machine to give high pressure alarms. The patient was unable to resolve the issue and terminated treatment. The patient was able to return his blood prior to termination therefore resulting in zero blood loss. The patient did not re-setup for continued treatment that day. There was no patient adverse reaction or injury reported. There was no medical intervention required. The bloodline product is not available to be returned to the manufacturer for evaluation. The exact event date is unknown; however it is known that the event occurred at some point after (b)(6) 2017 and before (b)(6) 2017; therefore, the event date is selected as (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2017-01025 |
| MDR Report Key | 7057710 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-24 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2016-09-15 |
| Date Added to Maude | 2017-11-24 |
| 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 | 2017-11-24 |
| Catalog Number | 03-2932-6 |
| Lot Number | 16LR01307 |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-11-24 |