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..
[186341798]
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
[186341799]
A user facility clinic manager (cm) reported that a blood leak occurred approximately one hour into a patient? S hemodialysis (hd) treatment. The blood leak was visually observed; blood was pooling on the floor underneath combi set lines and the blood pump assembly. The machine did not alarm. The patient was dialyzing on a fresenius 2008t machine with a fresenius optiflux 160nre dialyzer and fresenius combi set bloodlines. The cm reported that one of the? Little triangle shaped spring-loaded holders? Beneath the blood pump had fallen off during treatment. The function of the holder is to keep the bloodline tubing in place. An exact leak location was not identified, and the cause of the leak was unknown. The cm suspected the bloodline had a tiny crack (or tear) in it. The cm mentioned the possibility that the bloodline tubing incurred damage when the holder fell off. However, the combi set was inspected for damage and nothing visible was found. Following the blood leak, the treatment was halted and the patient? S blood was not returned. Estimated blood loss (ebl) was approximately 300 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 was able to complete treatment after being re-setup with new supplies on a different machine. Following the incident, the machine was pulled from service for evaluation. The biomedical technician at the facility replaced the bloodline holder and then put the machine through functional testing. The machine passed all functional testing and was subsequently returned to service. The combi set was reportedly available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00132 |
| MDR Report Key | 9641900 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-29 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-09-23 |
| 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 | 19KR01802 |
| 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 |