MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-01 for HOME HEMO COMBI SET FOR CANADA 03-2932-6 manufactured by Fresenius Medical Care North America.
[48629892]
(b)(4) the reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the lot number of the suspect device was not provided. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. A manufacturing review was performed of the products shipped to the dialysis center for the six (6) month time frame which immediately preceded the event occurrence date. This review included the lot numbers for all bloodline tubing sets shipped to this account within the selected time frame. A records review was performed on each identified 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. A review of the batch production records did not reveal a probable cause for the customer complaint. There were no non-conformances identified that relate to the reported event, and all lots met release criteria. Therefore, the reported adverse event was not able to be confirmed as it relates to the fresenius bloodline.
Patient Sequence No: 1, Text Type: N, H10
[48629893]
A user facility reported a serious unexpected blood loss event that occurred with a nocturnal at home hemodialysis (hd) patient. Prior to initiating the hd treatment, the patient took a sleeping pill. The treatment was successfully completed, however, when the patient attempted to return the blood within the circuit, the bloodline connections were not setup properly. The patient incorrectly attached the venous line to the y connector at the saline junction, instead of attaching the arterial line to the y connector. When the patient started the return, blood filled the saline bag instead of being returned to the patient. The patient reportedly felt dizzy and realized the connection error. The patient took a taxi to the clinic where blood was drawn and he spoke with a physician. The patient presented to the clinic with hypotension. The patient was given a bolus of normal saline while in the clinic. The patient's estimated blood loss (ebl) was noted as being approximately 500cc. The patient was not admitted to the hospital. The patient's current condition was noted as being "very stable. " the complaint device is not available to be returned for evaluation by the manufacturer as it was discarded by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2016-00324 |
| MDR Report Key | 5764699 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-01 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-05-25 |
| Date Mfgr Received | 2016-06-02 |
| Date Added to Maude | 2016-07-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CNOR TANYA TAFT |
| 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 FOR CANADA |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-07-01 |
| Catalog Number | 03-2932-6 |
| ID Number | 00840861101108 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2016-07-01 |