MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-19 for HOME HEMO COMBI SET 03-2962-3 manufactured by Fresenius Medical Care North America.
[53460448]
(b)(4) 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
[53460449]
A home hemodialysis (hd) nurse reported to technical service a blood loss event that occurred during a patient's treatment. During the initial set-up, the patient's dialyzer became clotted. It is unknown if the patient was using heparin or not. The patient's blood was not returned and the entire circuit was discarded. The estimated blood loss (ebl) from this initial set-up was approximately 200ml. The machine was subsequently set-up with new supplies and the treatment was restarted. Shortly after restarting treatment, an alarm went off indicating there was air in the lines. (the patient was back in treatment at the time). The alarm could not be cleared and the technician supporting the call advised the nurse to restart the patient's treatment with new supplies (for a second time). Following the air detector alarm, and since there appeared to be no leaks or malfunctions, the majority of the patient's blood was returned. However, it was reported that there was red tinged saline in the venous drip chamber. Though minuscule, this information suggests there was blood loss from this second set-up. The disposable supplies from this set-up were also discarded. Ebl from the disposal of this circuit was approximately 50ml (at most). The patient was able to successfully complete treatment after restarting a second time (on the same machine). The patient's total ebl was approximately 250ml. No patient adverse effects were experienced and no medical intervention was required as a result of these reported events. The machine was reportedly functioning properly and alarmed appropriately. No machine repairs or calibrations were needed. The complaint devices were not available for evaluation as they were reportedly discarded.
Patient Sequence No: 1, Text Type: D, B5
[56040510]
The complaint device was not returned for analysis; however, a case of companion samples from the distribution center were made available to the manufacturer for physical evaluation. A visual examination was performed on the tubing sets of the companion samples; no defects or irregularities were identified. The tubing sets were found to be visually acceptable. One (1) companion sample was then selected at random, and then tested using a 2008t hemodialysis machine for simulated use. The bloodline was able to be primed with no visible issues. During the simulated use test, fluid flowed through the lines without issue. There were no observations of a leak or air bubbles and no level variation of the venous or arterial drip chambers was visible to indicate the introduction of air into the blood circuit. The device worked as intended with no noted abnormalities and no defects identified. A records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event. In addition, the batch record review confirmed the labeling, material, and process controls were within specification. The lot passed all release criteria. The investigation into the cause of the reported problem was not able to confirm the failure mode. The reported defect of air pulled into lines was not able to be duplicated. Although the evaluation of the companion sample confirmed that the device functioned fully as designed and met specification, a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual complaint device. Therefore, the complaint has been deemed unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[56040511]
A case of companion samples from the reported lot was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2016-00428 |
| MDR Report Key | 5889375 |
| Date Received | 2016-08-19 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-07-22 |
| Date Mfgr Received | 2016-09-29 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2016-08-19 |
| 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 | MR. THOMAS JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS CP 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME HEMO COMBI SET |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-08-19 |
| Returned To Mfg | 2016-08-22 |
| Catalog Number | 03-2962-3 |
| Lot Number | 16BR01134 |
| ID Number | 00840861100330 |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMAULIPAS CP 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-19 |