MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 750

Model Number N/A

Device Problem Misconnection (1399)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

The customer stated that they have recently found one of the cryomacs freezing bags 750 (cfb) with a potential assembling defect.They attached the photograph of a cap, which does not seem to have been assembled correctly.The inner section seems to be cross-threaded in the port and has become jammed.On a second photograph which showed the package, the problem was picked up in the pre-process checks and it has not yet been opened.The processing operator was also concerned that the sterility of the inside of the line/pack may have been compromised by this.Therefore the affected bag was not used for freezing purposes.The failure was detected when the bags were received.Therefore not patient's cellular material was compromised and as a result any risk for patients could be ruled out.

• Brand Name: CRYOMACS FREEZING BAG 750
• Type of Device: CRYOMACS FREEZING BAG 750
• 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: 5813646
• MDR Text Key: 50178474
• Report Number: 3005290010-2016-00079
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 200-074-403
• Device Lot Number: 6151027008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization