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 2020-01-27 for CUSTOM COMBI SET 03-2722-9 manufactured by Erika De Reynosa, S.a. De C.v..
[188808643]
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
[188808644]
A user facility registered nurse (rn) reported that a blood leak occurred approximately four minutes into a patient? S hemodialysis (hd) treatment. Blood was visually observed leaking from a? Crack? In the arterial heparin line (on the combi set). Upon follow up, the rn stated that the crack in the line was located close to where it connects to the heparin pump. The rn described the leak as a slow drip of blood. The machine, a fresenius 2008t, did not alarm. A fresenius optiflux dialyzer was also used for the treatment. The patient? S treatment was immediately halted after the blood leak was identified. The patient? S blood was not returned; estimated blood loss (ebl) was approximately 100 ml. The rn confirmed 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 a different machine. The combi set was reportedly available to be sent back for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00123 |
| MDR Report Key | 9634219 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-27 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-07-06 |
| Date Added to Maude | 2020-01-27 |
| 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 | 2020-01-27 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 03-2722-9 |
| Catalog Number | 03-2722-9 |
| Lot Number | 19JR01132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-27 |