MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-11 for CUSTOM COMBI SET W/SPLIT SEPTUM 03-2630-6 manufactured by Erika De Reynosa, S.a. De C.v..
[179259954]
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, custom combi set and the adverse events of needle dislodgement, blood loss and hypovolemia requiring hospitalization and the infusion of prbcs. Causality for the events is attributed to the patient? S venous fistula needle (not a fresenius product) becoming dislodged during hd therapy; however, it is unknown how the needle became dislodged. Although access needle dislodgement is uncommon, these events can result in serious injury, significant blood loss and even death. Additionally, venous needle dislodgements are known to occur without triggering a venous pressure alarm due to the back pressure created by the narrow-bore needles or partial dislodgement. Based on the information available, the 2008t hemodialysis system can be disassociated from the events, as there is no evidence or indication a 2008t hemodialysis system malfunction caused or contributed to the serious adverse events. The needle dislodgement occurred at the point where the needle contacts the skin. Additionally, there is no evidence the 2008t hemodialysis system failed to perform as expected in relation to the events. Machine alarms may not occur in every blood loss situation. 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
[179259955]
It was reported that a patient with renal failure on hemodialysis (hd) for renal replacement therapy (rrt) felt unwell during their hd treatment on (b)(6) 2020. The patient was reportedly in the acute dialysis unit at a hospital, transported from the rehabilitation department. Upon evaluation, it was discovered that the patient? S venous fistula needle dislodged, and the patient sustained blood loss of approximately 1 l. The needle tip was sitting against the patient? S skin. The machine, a fresenius 2008t hemodialysis system, did not alarm. The needle was connected to a fresenius custom combi set, which was reportedly discarded after use. The patient was given 1 l of normal saline and was admitted for the transfusion of 2 units of packed red blood cells (prbcs). The patient was hospitalized overnight and discharged on (b)(6) 2020. Subsequent attempts to obtain additional information have thus far proven unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00187 |
| MDR Report Key | 9696505 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-02-11 |
| 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 W/SPLIT SEPTUM |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2020-02-11 |
| Model Number | 03-2630-6 |
| Catalog Number | 03-2630-6 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-11 |