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 2020-02-18 for COMBISET ACCESS FLOW REVERSE CON TWISTER 03-2794-0 manufactured by Erika De Reynosa, S.a. De C.v..
[184433039]
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
[184433040]
It was reported that the heparin pump line disconnected from line set at insertion site during a patient's hemodialysis (hd) treatment, interrupting treatment. Upon follow-up with the clinic manager (cm), it was confirmed that the leak occurred from the port where the heparin line connects to the rest of the bloodline. The machine, a fresenius 2008t machine, did not alarm as the leak was reported to be an external leak. There were no loose connections or issues noted during priming. The patient? S estimated blood loss (ebl) was less than 100 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on a same machine and treatment completed successfully with new supplies. The complaint device is not available to be returned to the manufacturer for evaluation because it was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00212 |
| MDR Report Key | 9720503 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-11-01 |
| Date Added to Maude | 2020-02-18 |
| 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 | 2020-02-18 |
| Model Number | 03-2794-0 |
| Catalog Number | 03-2794-0 |
| Lot Number | 19NR01048 |
| 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 | 2020-02-18 |