MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-20 for CLINIMACS? TUBING SET LS N/A 162-01 manufactured by Miltenyi Biotec Gmbh.
[50025726]
Patient Sequence No: 1, Text Type: N, H10
[50025727]
The customer reported that basically, the run started with "loading cells" but did not drain the product bag completely. Approximately half of the product went into the column. It did not rinse the pall filter and the product bag, before kicking right into the first wash. The product had severe clumping and was clogging up the fall filter. This was also creating bubbles in the drip chamber directly below the pall filter and the liquid sensor. The customer could see if the bubbles in the liquid sensor triggered the instrument while expecting that the entire product was loaded, but than it should have gone directly into rinsing the filter and bag before starting the first wash, but it did not. The customer called the miltenyi biotec inc. Hotline and the miltenyi biotec representative helped them to use another tubing set to complete the run. Therefore any risk for the patient could be ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005290010-2016-00078 |
| MDR Report Key | 5809618 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-20 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-06-23 |
| Date Mfgr Received | 2016-06-23 |
| Device Manufacturer Date | 2015-01-08 |
| Date Added to Maude | 2016-07-20 |
| 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 | 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 LS |
| Generic Name | CLINIMACS? TUBING SET LS |
| Product Code | OVG |
| Date Received | 2016-07-20 |
| Model Number | N/A |
| Catalog Number | 162-01 |
| Lot Number | B2304 |
| Device Expiration Date | 2017-09-02 |
| 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 | 2016-07-20 |