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

Model Number N/A

Device Problem Break (1069)

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

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was asked by miltenyi biotec (b)(4) to fill out the complaint questionnaire cryomacs.The questionnaire was send back on 02nd august 2016.Furthermore photos of the affected freezing bag itself were available to perform an investigation.The investigator is able to state that there was no deviation during the production process recorded.The production batch l/n 6140711005 contained (b)(4) cfbs.This was the first complaint acknowledged for this batch of cfb by miltenyi biotec (b)(4).In general, the complaint rate based on sold freezing bags is regarded to be very rare (b)(4).

Event Description

The cryomacs© freezing bag 50 (cfb) was stored in liquid nitrogen.When the cfb was thawed, it got broken and the complete cellular material was found in the overwrap bag.The patient could be treated because there was still sufficient cellular material in place {the cellular material from the overwrap bag could be used together with an extra-portion of antibiotics to raise the safety margin).Therefore any risk for the patient could be ruled out.

• 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: 5903657
• MDR Text Key: 52985820
• Report Number: 3005290010-2016-00082
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Notification
• Type of Report: Initial
• Report Date: 08/11/2016

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: Health Professional
• Device Expiration Date: 06/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 200-074-400
• Device Lot Number: 6140711005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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