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 2020-03-24 for COMBISET ACCESS FLOW REVERSE CON TWISTER 03-2794-0 manufactured by Erika De Reynosa, S.a. De C.v..
[184853133]
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
[184853134]
A hemodialysis (hd) user facility reported a combi set blood leak that occurred shortly after initiation of a patient? S hd treatment. The blood was reported to be leaking from the luer lock connector, close to where the venous transducer connects. Upon follow up, it was reported that a crack was identified on the luer lock connector. This was believed to be the origin of the leak. The patient? S treatment was immediately halted after the leak was identified. The lines were clamped to prevent further leakage and the combi set was replaced with a new one. The patient? S blood loss was minimal; estimated blood loss (ebl) was 10 ml. The patient was dialyzing on a fresenius 2008t machine and was using a fresenius optiflux dialyzer. The machine did not alarm. It was confirmed that there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event. The patient was able to complete their treatment after the combi set was replaced with a new one. The combi set bloodline was reported to be available for a manufacturer evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00352 |
| MDR Report Key | 9870750 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-10-02 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2020-03-24 |
| Model Number | 03-2794-0 |
| Catalog Number | 03-2794-0 |
| Lot Number | 19NR01029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-24 |