MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number	2C8720
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred between (b)(6) 2019.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a clearlink system y-type blood/solution set came apart during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation contaminated with blood.During visual inspection, the tubing was observed separated from the blood filter chamber (which was not returned by the customer).The reported condition was verified.Due to the condition of the sample, no further testing can be performed; therefore, the cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9323701
• Report Number: 1416980-2019-06334
• Device Sequence Number: 419630
• Product Code: BRZ
• UDI-Device Identifier: 00085412049083
• UDI-Public: (01)00085412049083
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K993120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: Other
• Device Catalogue Number: 2C8720
• Device Lot Number: R18J06072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1