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 2020-01-29 for CUSTOM COMBI SET 03-2722-9 manufactured by Erika De Reynosa, S.a. De C.v..
[186156170]
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
[186156171]
A user facility registered nurse (rn) reported a blood leak that occurred two to three minutes into a patient? S hemodialysis (hd) treatment. At first, an air leak detector alarm went off. The rn tried identifying where the air leak was coming from and noted blood on the base of the machine. By utilizing a gauze strip, the rn was able to trace the leak to the arterial chamber on the combi set. The rn believed there was a hairline crack on the bottom of the arterial chamber, where the hard plastic connects to the tubing that feeds into the blood pump. Reportedly, the location of the damage was hard to identify because the lines were filled with blood. The rn believes that air entered the system through the arterial chamber. There were no changes or disruptions in pressure which could have caused the issue. The patient was dialyzing on a fresenius 2008t machine and was using a fresenius optiflux dialyzer. The patient? S blood was not returned; estimated blood loss (ebl) was approximately 250 ml. 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 successfully completed their treatment after being re-setup with new supplies on the same machine. The combi set was not available to be returned for physical evaluation, as it was reportedly discarded after use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00140 |
| MDR Report Key | 9645165 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-09-28 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Model Number | 03-2722-9 |
| Catalog Number | 03-2722-9 |
| Lot Number | 19LR01287 |
| 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 | 2020-01-29 |