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 2019-04-26 for COMBISET ACCESS FLOW REVERSE CON TWISTER 03-2794-0 manufactured by Erika De Reynosa, S.a. De C.v..
[143822079]
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
[143822080]
A user facility clinic manager reported a blood leak that occurred 11 minutes after the beginning of the patient? S hemodialysis (hd) treatment. The blood leak was visually observed at arterial tubing of the bloodline. There was no damage noticed on the bloodline. The patient? S estimated blood loss (ebl) was approximately 99 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient successfully completed treatment on the same machine with new supplies. The complaint device was saved and is available to be returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2019-00642 |
| MDR Report Key | 8556928 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-26 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-07-22 |
| Date Added to Maude | 2019-04-26 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 1100 E. MILITARY HWY., SUITE C |
| Manufacturer City | PHARR TX 78577 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78577 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBISET ACCESS FLOW REVERSE CON TWISTER |
| Generic Name | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
| Product Code | KOC |
| Date Received | 2019-04-26 |
| Catalog Number | 03-2794-0 |
| Lot Number | 18JR01040 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-04-26 |