MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-18 for CLINIMACS TUBING SET 161-01 manufactured by Miltenyi Biotec Gmbh.
[40662941]
The customer did not send tubing set or pictures of the tubing set back, nor did they fill out complaint questionnaire, therefore thorough investigation could not be performed.
Patient Sequence No: 1, Text Type: N, H10
[40662942]
Upon setting up the clinimacs tubing set, on the clinimacs plus instrument and initiating the priming a leak below valve 5 was observed by the customer. A new tubing set was installed and the cell separation was properly performed. There was no risk to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00054 |
| MDR Report Key | 5510286 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-18 |
| Date of Event | 2015-11-19 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2016-03-18 |
| 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 TUBING SET |
| Generic Name | CLINIMACS TUBING SET |
| Product Code | OVG |
| Date Received | 2016-03-18 |
| Catalog Number | 161-01 |
| Lot Number | B224 |
| Device Expiration Date | 2016-02-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-03-18 |