MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-04 for HOME HEMO COMBI SET 03-2962-3 manufactured by Fresenius Medical Care North America.
[38104312]
(b)(4). A supplemental report will be filed upon completion of the plant investigation.
Patient Sequence No: 1, Text Type: N, H10
[38104313]
During follow up with a k at home patient, she reported after treatment began, the venous pressure read "0". She attached a new venous line and still had a "0" reading. She then changed the needle and noticed that the blood on the venous side was black. She thought there may have been a crack in the tubing. She returned blood on arterial side and reports blood loss of less than 200cc from venous side. She discarded the tubing. She did not continue treatment that day. The patient set up and ran a treatment the next day (b)(6) 2015) without any problems.
Patient Sequence No: 1, Text Type: D, B5
[39537408]
(b)(4). The device was not returned to the manufacturer for physical evaluation, therefore, the failure mode cannot be confirmed. A manufacturing review was performed of the products shipped to the complainant during a three (3) month time frame for lot numbers received. A records review was performed on the sole lot identified. An investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, the batch record review confirmed the labeling, material, and process controls were within specification. A labeling evaluation was performed. No indication of labeling being a contributing factor in the occurrence of this complaint was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2016-00046 |
| MDR Report Key | 5411595 |
| Date Received | 2016-02-04 |
| Date of Report | 2016-02-29 |
| Date of Event | 2015-12-18 |
| Date Mfgr Received | 2016-02-18 |
| Date Added to Maude | 2016-02-04 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | REYNOSA |
| Manufacturer Street | ERIKA DE REYNOSA PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | 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 | 2016-02-04 |
| Catalog Number | 03-2962-3 |
| Lot Number | UNKNOWN |
| ID Number | 00840861100330 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | ERIKA DE REYNOSA REYNOSA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-04 |