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

Catalog Number	4C8723
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot # r18i13095, r18j24117, and r18j25117.(b)(4).Of the three (3) events, the device for one (1) was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was inspected which provided evidence of a leak between the cap and the filter housing.The reported condition was verified.The cause of the reported condition was a manufacturing issue related to the raw material of the filter.For two (2) events, the evaluation has not yet been started.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot r18i13095.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 there were three (3) events of leaking clearlink system y-type blood/solution sets.In one (1) event, one set was leaking from an unspecified location.In two (2) events, an unspecified number of clearlink system y-type blood/solution sets came apart where the seam meets the chamber which resulted in leakage.For all three (3) event, the leaks were observed during patient therapy and there were no patient consequences.No additional information is available.
Additional Manufacturer Narrative
Additional information : eighteen (18) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure testing and clear passage under water testing were performed.17 of the samples passed testing with no issues noted.A hole was observed in the hand pump of one of the samples.The reported condition was verified for one sample.The cause of the condition was determined to be a manufacturing issue.This issue is being further investigated.A batch review was conducted for lot r18j25117 and r18j24117 and there were no deviations found related to this reported condition during the manufacture of these lots.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 - CARTAGO; cartago
• MDR Report Key: 8560564
• Report Number: 1416980-2019-02378
• Device Sequence Number: 2193586
• 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,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: No Information
• Device Catalogue Number: 4C8723
• Device Lot Number: SEE H10
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1