MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500

Model Number 74402

Device Problem Material Integrity Problem (2978)

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

Event Date 04/30/2020

Event Type  malfunction  

Event Description

Miltenyi biotec was informed about the incident by the (b)(6).Until now it was not possible to obtain further information from the initial reporter, despite several attempts.Based on the provided information: "stammzellbeutel beim auftauen defekt." it can only be assumed that a cryomacs freezing bag was broken or leaked after thawing.Based on the fact that the incident was reported, it is likely that the material was lost due to the incident.It remains unknown if or how a patient was affected.Typically backup material is available for treatment.With the information available no investigation is possible.Complaints for the lot have been reviewed and the incident rate is very low with (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 500
• Type of Device: CRYOMACS FREEZING BAG 500
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 10217362
• MDR Text Key: 199852491
• Report Number: 3005290010-2020-00017
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 04049934000294
• UDI-Public: 04049934000294
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 74402
• Device Catalogue Number: 200-074-402
• Device Lot Number: 6181214013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1