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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750
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MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750 Back to Search Results
Catalog Number 200-074-403
Medical Device Problem Code Material Puncture/Hole (1504)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/18/2021
Type of Reportable Event Malfunction
Event or Problem Description
Customer used the cryomacs bag as a cell collection bag for the clinimacs plus (via leur connection).During elution, the customer noticed that the tube (likely the eva tubing) started to leak, resulting in the loss of product.A photo and video are provided.The affected tube was returned.The patient did not receive the treatment, the procedure for the treatment is a clinimacs cd34 + depletion of cd45ra and on day 7 cd56 infusion, the cd34 and the cd45ra depletion went well and the patient got the cells but it was not possible to infuse the cd56 cells with the potential risk of the reactivation of hepex vi.
 
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Brand Name
CRYOMACS FREEZING BAG 750
Common Device Name
CRYOMACS FREEZING BAG 750
Manufacturer (Section D)
MILTENYI BIOTEC B.V. & CO. KG
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM  51429
MDR Report Key12009069
Report Number3005290010-2021-00011
Device Sequence Number4601321
Product Code KSR
UDI-Device Identifier04049934000300
UDI-Public4049934000300
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
BK090020
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number200-074-403
Device Lot Number7200300410
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2021
Initial Report FDA Received Date06/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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