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 2020-03-06 for CLIC BLOOD CHAMBER CL10041021 manufactured by Erika De Reynosa, S.a. De C.v..
[184175258]
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
[184175259]
A user facility registered nurse (rn) reported that a clic blood chamber blood leak occurred three hours and eighteen minutes into a patient? S hemodialysis (hd) treatment. Blood was observed dripping from the bottom of the circular chamber, above where the device connects to the dialyzer. Though nothing was visible, the rn stated there must have been a slight crack on the device. The machine, a fresenius 2008t, did not alarm. The patient was dialyzing with fresenius bloodlines and a fresenius optiflux dialyzer. Blood leak test strips were not used. No damage was identified on the dialyzer or the bloodlines. After the blood leak was noticed, the treatment was ended. The patient? S estimated blood loss (ebl) was approximately 50 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? S treatment was not restarted, however, there were no adverse effects due to the incomplete treatment. The clic blood chamber was discarded, and was therefore not available for manufacturer evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00290 |
| MDR Report Key | 9802910 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-06 |
| 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 | CLIC BLOOD CHAMBER |
| Generic Name | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
| Product Code | KOC |
| Date Received | 2020-03-06 |
| Model Number | CL10041021 |
| Catalog Number | CL10041021 |
| Lot Number | 19PR01009 |
| 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 | 2020-03-06 |