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 2020-02-05 for CUSTOM COMBI SET 03-2722-9 manufactured by Erika De Reynosa, S.a. De C.v..
[186149011]
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
[186149012]
A user facility clinic manager (cm) reported that a blood leak occurred less than three minutes into a patient? S hemodialysis (hd) treatment. The blood leak was reportedly coming from the fresenius combi set bloodline. The operator noted blood dripping onto the base of the machine shortly after treatment was initiated, and photographs provided by the cm verified the presence of blood at this location. The leak was traced to the red port on the combi set, where the heparin line connects. The cm stated there was a visible crack in the port. No other damage was found. No leaks were noted during the priming. The cm stated the machine, a fresenius 2008t, did not alarm. The patient was also using a fresenius optiflux dialyzer. As soon as the blood leak was noticed, the operator clamped the lines and halted the treatment. Most of the patient? S blood was returned; the estimated blood loss (ebl) was approximately 5 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 the same machine. The combi set was not available to be returned for evaluation as it was reportedly discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00167 |
| MDR Report Key | 9673569 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-09-12 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Model Number | 03-2722-9 |
| Catalog Number | 03-2722-9 |
| Lot Number | 19LR01136 |
| 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 | 2020-02-05 |