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 2019-11-05 for CUSTOM COMBI SET 03-2722-9 manufactured by Erika De Reynosa, S.a. De C.v..
[165247792]
Clinical review: there is a temporal and causal relationship between hd therapy utilizing the custom combi set and the patient event of blood loss due to a hole in the venous bloodline during treatment requiring a transfusion of red blood cells. This patient has chronic anemia with a low hgb level and in addition was being tested for a gastrointestinal bleed (guaiac stool sample ordered) as a second source of low hemoglobin levels; therefore, any blood loss can negatively affect the patient? S stability. The reported hole in the venous line caused the patient to lose an approximate 150ml of blood which led to the required intervention. The combi set was not returned for evaluation and the allegation could not be confirmed. The antibiotic administration was a precaution for possible contamination due to the leak. Based on the available information reported by the customer, the hole in the venous line of the custom combi set is the cause of the patient adverse event. 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
[165247793]
A hemodialysis biomedical engineer (biomed) reported that a patient was sent to the emergency room (er) due to blood loss resulting from a hole in the venous line during treatment. The patient was initiated on hemodialysis (hd) therapy, utilizing the fresenius 2008t machine with custom combi set. Shortly after the start of treatment, staff members noticed blood between the chair and the dialysis machine. Blood was also noted to be squirting from the venous line of the dialysis extracorporeal circuit. There was a hole in the venous line confirmed by the clinic staff. The patient? S blood was returned, and the lines clamped. The estimated blood loss (ebl) of the blood which leaked was 150ml. The physician was present at chairside and evaluated the patient. It was advised that the patient be transported to the emergency room (er) via emergency medical services (ems) as a precaution due to the patient? S previous hemoglobin (hgb) levels two days prior being 7. 4. This patient has chronic anemia for which micera (dose, route, frequency and duration unknown) is prescribed. The patient was treated in the er with antibiotics, 1 dose of gentamycin and vancomycin (dose and route unknown) and 1 unit of packed red blood cells (prbc). The patient also was able to complete hd therapy. The patient? S hgb was checked and reportedly was good (unspecified value). The patient was released from the er less than eight hours later and returned for their regularly scheduled hd therapy at the clinic two days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2019-01700 |
| MDR Report Key | 9279875 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-05 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2019-05-30 |
| Date Added to Maude | 2019-11-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2019-11-05 |
| Catalog Number | 03-2722-9 |
| Lot Number | 19ER01088 |
| 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 | 2019-11-05 |