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 2018-10-18 for PATIENT CONNECTOR CLIP (NON-STERILE) 04-9100-1 manufactured by Erika De Reynosa, S.a. De C.v..
[124186490]
Clinical investigation conclusion: a temporal relationship with the adverse events of the patient? S blood loss, dyspnea and nausea and the fresenius blood lines and hemaclip exist. However, there is no documentation of any defects at the connection site of the venous blood line to the catheter or any other venous blood line issues. The initial report from the clinic did state that the bloodlines were reversed during treatment and that they were found to be loose when the blood leak was discovered, however, follow up information documented that it was unknown if there was any loose connection. It is unknown what may have occurred to cause the leak at the connection with ten minutes remaining in the treatment. There is no documentation to state if the patient access site was uncovered. Reportedly, the hemaclip was intact on the venous line, but it is unknown what make of catheter was utilized and if it was compatible with the hemaclip. The adverse event was a direct result of the patient? S dialysis venous line leaking at the connection leading to the blood loss, nausea and dyspnea with subsequent hospitalization.
Patient Sequence No: 1, Text Type: N, H10
[124186491]
On (b)(6) 2018 a hemodialysis (hd) clinic reported that a patient with end stage renal disease (esrd) complained of shortness of breath and nausea during treatment. The bloodlines had been reversed earlier in the treatment and staff noted the venous bloodline was loose from the central venous catheter (cvc) (not a fresenius product) arterial limb with hemoclip intact. The estimated blood loss of the patient was 400-500ml. The patient was administered oxygen and emergency medical services (ems) was called and transferred the patient to the hospital where they were admitted. Additional information was obtained through follow up with the clinic manager on (b)(6) 2018. This female patient on thrice weekly hd therapy initiated her dialysis treatment on (b)(6) 2018 utilizing the optiflux 160nre dialyzer on the fresenius 2008t machine. The treatment was scheduled for four hours. With approximately 10 minutes remaining in treatment a blood leak was observed at the connection between the venous bloodline and the cvc arterial limb connection. The patient then complained of nausea and dyspnea. Per the clinic manager, it was not noted if there were any loose connections, however, there was no visible damage or defect seen on the bloodlines. Treatment was stopped and the patient was placed on oxygen. The patient was transported to the hospital via ems and admitted. The estimated blood loss was 500ml. Hospital course is unknown and discharge date is not known. The patient has since returned to their regularly scheduled hd therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2018-01623 |
| MDR Report Key | 7980122 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-18 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2017-05-15 |
| Date Added to Maude | 2018-10-18 |
| 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 | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT CONNECTOR CLIP (NON-STERILE) |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2018-10-18 |
| Returned To Mfg | 2018-11-01 |
| Catalog Number | 04-9100-1 |
| Lot Number | 17ER06003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-18 |