MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750

Catalog Number 200-074-403

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

At two occasions (b)(6) 2021; two different patients) the user observed a breakage of a cryomacs bag 750.The breakage occured at the central port.The bag was thawed in a waterbath with an overwrap bag.Half of the content drained into the overwrap bag.For one patient the cells have been used, for the other enough material was available from a backup bag.The affected bag was not used for this case.The customer has been asked to provide photos and to filled in a questionnaire, but did not yet respond.This information is necessary to investigate the issue and determine a root cause.An analysis of the complaint database showed, that this failure was not reported before for this lot.The incident rate is (b)(4).

• Brand Name: CRYOMACS FREEZING BAG 750
• Type of Device: CRYOMACS FREEZING BAG 750
• 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: 13042575
• MDR Text Key: 285627056
• Report Number: 3005290010-2021-00016
• Device Sequence Number: 1
• Product Code: KSR
• UDI-Device Identifier: 00404993400300
• UDI-Public: 404993400300
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK090020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200-074-403
• Device Lot Number: 7210600087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1