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 2020-01-13 for COMBI SET 03-2622-3 manufactured by Erika De Reynosa, S.a. De C.v..
[186732336]
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
[186732337]
A user facility nurse reported that a combi set blood leak occurred approximately 120 minutes into a patient? S hemodialysis (hd) treatment. The blood leak was coming from the arterial chamber on the combit set. There was a? Crack? Identified on the arterial chamber; the crack was not noticed prior to initiation of treatment. A photograph of the cracked arterial chamber was provided to the manufacturer, and the damage is clearly visible. The machine, a fresenius 4008s machine, did not alarm. Blood leak test strips were not used. There was nothing unusual noted during the prime, and no leaks occurred during the priming process. As soon as the blood leak was observed, treatment was halted, and the patient was set up with new supplies on the same machine. The patient? S estimated blood loss (ebl) was approximately 2 ml. The patient completed their treatment, and 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 complaint device was not available to be returned for evaluation as it was reportedly discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00049 |
| MDR Report Key | 9583020 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-01-13 |
| 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 | COMBI SET |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2020-01-13 |
| Model Number | 03-2622-3 |
| Catalog Number | 03-2622-3 |
| Lot Number | 19LR01060 |
| 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 | 2020-01-13 |