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 2017-09-29 for DIALYZER manufactured by Ogden Manufacturing Plant.
[87792385]
A supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[87792386]
A fresenius regional equipment specialist (res) was called onsite to repair a 2008k hemodialysis (hd) machine with ultrafiltration (uf) pump out of specification. It was reported a hemodialysis (hd) patient coded while receiving treatment on the machine. The res recalibrated the uf pump to resolve the issue. The machine was returned to service. Follow-up was made with the facility registered nurse (rn), who stated she was unwilling to disclose any patient information due to patient privacy/confidentiality. The rn stated the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired. The rn stated the facility used fresenius dialyzers, bloodlines, acid concentrate and bicarb concentrate delivered via jugs. The catalog and lot numbers of the fresenius products were unknown. No samples were obtained to be returned for evaluation. Although requested, no further patient specific or event related details were made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2017-00313 |
| MDR Report Key | 6904989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-29 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-09-29 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | 475 WEST 13TH STREET |
| Manufacturer City | OGDEN UT 84404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYZER |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2017-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Manufacturer Address | 475 WEST 13TH STREET OGDEN UT 84404 US 84404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-09-29 |