MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8537

Device Problems Backflow (1064); Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported an unspecified ¿clearlink continu-flo solution set¿ backflowed.After approximately one hour into a two hour chemotherapy infusion, ¿the secondary bag was empty and that the drip chamber for the primary set was filled.¿ the primary and secondary bags both had volumes of 250ml.When the backflow was observed, the ¿primary bag also increased to an estimated volume of 363 ml¿ and the other ¿half of the secondary bag infused while the remaining went back up into the primary bag.¿ there was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

F10/h6: device codes correction: 1064 (previously 1522).G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test including pressure test and clear passage test was performed with no issues noted.A backflow functional testing was performed which revealed that the check valve did not work according to the procedure, the result were not satisfactory.The reported condition was verified.The cause of the condition is related to a supplier manufacturing issue.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 CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9928795
• MDR Text Key: 186572142
• Report Number: 1416980-2020-01982
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 2C8537
• Device Lot Number: R19K25012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED BAXTER PRIMARY SET; UNSPECIFIED CHEMOTHERAPY; UNSPECIFIED PUMP; UNSPECIFIED BAXTER PRIMARY SET; UNSPECIFIED CHEMOTHERAPY; UNSPECIFIED PUMP