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 2020-01-15 for CUSTOM COMBI SET W/SPLIT SEPTUM 03-2621-5 manufactured by Erika De Reynosa, S.a. De C.v..
[178352261]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: there is a temporal relationship between the patient? S hemodialysis treatment utilizing the custom combi set and blood loss with drop in hemoglobin requiring two units of prbc to be transfused. Additionally, there is a causal relationship between the adverse event and the reported puncture holes in the venous tubing leading to patient blood loss. The tubing was disposed of and not returned for evaluation, but the allegation of the tubing punctures is supported by the report of the patient blood loss with transfusion due to anemia (drop in hgb 9. 6 to 7. 8) any significant change in hgb values is dangerous for dialysis patients. Hemoglobin concentrations are associated with an increased risk of morbidity and mortality in chronic kidney disease. Although no leak was noted prior to start of treatment, the manual for the hemodialysis machine states to check the bloodlines for leaks once treatment has been initiated. Based on the available information, the venous tubing blood leak caused the patient? S significant drop in hemoglobin requiring administration of two units of prbc.
Patient Sequence No: 1, Text Type: N, H10
[178352262]
A hemodialysis (hd) outpatient clinic reported that a blood leak occurred an hour and fifteen minutes into a patient? S hd treatment on (b)(6) 2019. The staff noticed blood leaking from behind the patient? S chair. The leak was reportedly coming from a hole in the venous line of the combi set. The patient? S estimated blood loss (ebl) was 500 ml. After the blood leak was discovered, the treatment was ended, the blood was cleaned up, and the patient was transferred to a new machine with stable vital signs. After completing treatment on the new machine, the patient was discharged in stable condition. The patient and their spouse were educated on signs of anemia and instructed to go to the emergency room (er) should any signs/symptoms appear. On (b)(6) 2019 the patient experienced chest pain and shortness of breath. The patient went to the er and was put under observation. The patient? S hemoglobin (hgb) on arrival to the er was 7. 8 which was a drop from the (b)(6) when it was 9. 6. The patient received two units of packed red blood cells (prbc) and was discharged to their home on (b)(6) 2019 with a hgb of 8. 7. The patient returned to the hd clinic on (b)(6) 2019 and has been continuing treatment without any further issues. Upon follow up with the user facility, it was reported that the hole in the venous tubing looked like a? Snake bite (two fang punctures)? [sic]. Reportedly, the staff has inspected all subsequent bloodlines from the lot, and nothing else has been found. The complaint device was not available to be returned for physical evaluation as it was reportedly discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2020-00066 |
| MDR Report Key | 9594306 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Model Number | 03-2621-5 |
| Catalog Number | 03-2621-5 |
| Lot Number | 19KR01001 |
| 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 | 2020-01-15 |