MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-01 for CLINIMACS PLUS INSTRUMENT 151-01 manufactured by Miltenyi Biotec Gmbh.
[41665557]
Device difficult to maintain - customer does not have preventive maintenance contract with miltenyi, the machine is very old, therefore difficult to maintain without routine maintenance. Process evaluation - miltenyi biotec service group has sent the customer a quote for service and is waiting for approval from customer. Service has quote out to customer.
Patient Sequence No: 1, Text Type: N, H10
[41665558]
The customer received an error message #12 on their clinimacs plus instrument (b)(4)after the sample had been loaded. The operator was not next to the instrument when the error appeared, however, the negative fraction had already been eluted. No fluid/cells had been eluted into the positive fraction. Error 12 reads magnet error - refer to manual. Miltenyi technical service was called immediately and guided the customer through 2 emergency procedures. They were able to rescue cells, therefore no harm was caused to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00061 |
| MDR Report Key | 5540901 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-01 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-01-27 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2016-04-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS NANCY JOHANSEN |
| Manufacturer Street | 85 HAMILTON ST |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6172180062 |
| Manufacturer G1 | MILTENYI BIOTEC GMBH |
| Manufacturer Street | FRIEDRICH-EBERT-STRASSE 68 |
| Manufacturer City | BERGISCH GLADBACH, 51429 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 51429 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIMACS PLUS INSTRUMENT |
| Generic Name | CLINIMACS PLUS INSTRUMENT |
| Product Code | OVG |
| Date Received | 2016-04-01 |
| Catalog Number | 151-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTENYI BIOTEC GMBH |
| Manufacturer Address | FRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |