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 2020-02-12 for CUSTOM COMBI SET 03-2742-9 manufactured by Erika De Reynosa, S.a. De C.v..
[184662893]
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
[184662894]
A user facility clinic manager (cm) reported that a blood leak occurred during a patient? S hemodialysis (hd) treatment. Blood was observed dripping onto the base of the machine approximately three hours into the patient? S treatment. The cm stated the treatment was nearly finished. The exact location of the leak was not found. The cm thinks there may have been a tiny pinhole or slice in the bloodline, however, no visible damage was identified. The cm said they squeezed the line to see where the blood was leaking from, and nothing happened. The cm stated that the blood may have begun clotting, preventing blood from passing through whatever damage in the line may have existed. The cm stated there were no leaks noted during the priming phase and was not sure what caused the leak. The machine, a fresenius 2008t, did not alarm. The machine was pulled from service and the biomedical technician discovered that a spring was missing from the bottom of the blood pump, where the bloodline enters the pump. The cm stated that the function of this spring is to hold the bloodline in place. A fresenius optiflux 160nre dialyzer was used for the treatment. After the blood leak was noticed, the treatment was halted. The cm stated the patient? S blood was not returned; estimated blood loss (ebl) was 200 ml. It was 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 declined to be re-setup with new supplies, and thus, the treatment was not completed. The combi set (bloodline) was not available to be returned for evaluation as it was reportedly discarded. It was confirmed that the missing spring was replaced on the machine, and the machine was then returned to service. There have been no further issues or reoccurrences on the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00193 |
| MDR Report Key | 9701143 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-02-12 |
| 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 | 2020-02-12 |
| Model Number | 03-2742-9 |
| Catalog Number | 03-2742-9 |
| Lot Number | 19NR01082 |
| 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 | 2020-02-12 |