MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS® TUBING SET LS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/26/2015

Event Type  malfunction  

Event Description

The customer reported there was a leak in the seal on the triple fork below the buffer spike of their clinimacs tubing set ls.Since the leak was detected prior to integrity test, no cellular material was affected and therefore no harm caused to the patient.The customer was asked to send back the tubing set for further investigation, but it had not arrived at (b)(6) at the time of this report.The customer did provide photographs, which do not have the resolution needed to identify the failure itself.Therefore, the root cause is speculative.The event happened at: (b)(6).

• Brand Name: CLINIMACS® TUBING SET LS
• Type of Device: CLINIMACS® TUBING SET LS
• 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: 5230480
• MDR Text Key: 31410687
• Report Number: 3005290010-2015-00017
• Device Sequence Number: 1
• Product Code: OVG
• UDI-Device Identifier: 04049934004834
• UDI-Public: 04049934004834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BH110018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2017
• Device Model Number: N/A
• Device Catalogue Number: 162-01
• Device Lot Number: B2304
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 03/01/2015
• 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