MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE LOW WEIGHT - LOW VOLUME; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	114435
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A batch review was conducted and there was no deviation found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation, however, eight retained samples were evaluated.Visual inspection and dimensional inspection did not identify any abnormalities that could have contributed to the reported condition.Simulated use testing was performed with retention samples, and it was determined that the sets could be loaded correctly.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at the beginning of patient treatment with a gambro cartridge low weight/low volume bloodline, the blood pump was not catching the tubing.The tubing segment became loose.The rn tried to adjust the tubing, however, it would not stay in place.Treatment was terminated without returning the extracorporeal blood to the patient.The blood loss was approximately estimated to 50ml.No clinical symptoms were reported; however, the patient had an "er visit".It was unknown if any medical intervention was provided.At the time of this report, the patient was ¿stabilized¿.No additional information is available.

• Brand Name: CARTRIDGE LOW WEIGHT - LOW VOLUME
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 7713456
• Report Number: 8030638-2018-00010
• Device Sequence Number: 11112211
• Product Code: FJK
• UDI-Device Identifier: 07332414112400
• UDI-Public: (01)07332414112400
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/24/2018
• Report Date (Section F): 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2020
• Device Catalogue Number: 114435
• Device Lot Number: 1000179062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHOENIX MACHINE
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 11
• Date Report Sent to FDA: 07/24/2018