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 2020-02-27 for CUSTOM COMBI SET 03-2722-9 manufactured by Erika De Reynosa, S.a. De C.v..
[184711072]
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
[184711073]
A registered nurse (rn) reported that a blood leak occurred approximately fifteen minutes into a patient's hemodialysis treatment. Blood was observed leaking externally from the bloodline, where the venous tubing exits the blood pump. There was no visible damage identified on the device, but there was suspected to be a pinhole on the tubing. The machine, a fresenius 2008t, did not alarm. A fresenius optiflux dialyzer was also used for the treatment. After the leak was identified, the treatment was halted. Blood from the arterial tubing was returned; however, blood in the venous tubing was not returned. The patient's estimated blood loss (ebl) was approximately 150 ml. 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 treatment after being re-setup with new supplies on the same machine. The bloodline was reportedly available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00257 |
| MDR Report Key | 9766089 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-12-02 |
| Date Added to Maude | 2020-02-27 |
| 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 | CUSTOM COMBI SET |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2020-02-27 |
| Model Number | 03-2722-9 |
| Catalog Number | 03-2722-9 |
| Lot Number | 19PR01148 |
| 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 | 2020-02-27 |