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

Catalog Number	4C8723
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 3 malfunction events.It was reported that three (3) clearlink blood recipient sets leaked.The reporter stated that when the anesthesia clinician attempted to use the hand pump of a manual blood pump iv set, the device separated between the inflow cap and the cylinder of the hand pump, leading to a leak of blood.This occurred prior to patient use.The reporter stated that this had previously occurred two additional times.Process step and patient involvement are unknown for the two additional events.No additional information is available.

• Brand Name: CLEARLINK BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8833300
• Report Number: 1416980-2019-04071
• Device Sequence Number: 14138920
• Product Code: BRZ
• UDI-Device Identifier: 00085412049076
• UDI-Public: (01)00085412049076
• Combination Product (Y/N): N
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 4C8723
• Device Lot Number: R18J24117
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1