MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 50

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

N/a.

Event Description

The customer complained that one cryomacs freezing bag 50 (cfb) was leaking at the bottom during filling with cord blood.As a result about 10 ml of the cellular material got lost.The customer believed that the reason for the leakage was insufficient welding at the bottom side of the affected cfb.The customer furthermore stated that the remaining cell sample was not enough for long-term storage but that actually no patient was harmed by the event.

• Brand Name: CRYOMACS FREEZING BAG 50
• Type of Device: CRYOMACS FREEZING BAG 50
• Manufacturer (Section D): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC GMBH; friedrich-ebert-strasse 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: nancy johansen ; 85 hamilton st; cambridge, MA 02139 ; 6172180062
• MDR Report Key: 5904228
• MDR Text Key: 53015606
• Report Number: 3005290010-2016-00083
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/20/2018
• Device Model Number: N/A
• Device Catalogue Number: 200-074-400
• Device Lot Number: 6150820023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1