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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 06/25/2018

Event Type  Injury  

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 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
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• Manufacturer (Section G): BAXTER HEALTHCARE - TIJUANA BAJA; blvd pacifico 10014; parque industrial pacifico; tijuana baja california CP 22 643; MX CP 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7713456
• MDR Text Key: 114809570
• Report Number: 8030638-2018-00010
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414112400
• UDI-Public: (01)07332414112400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2020
• Device Catalogue Number: 114435
• Device Lot Number: 1000179062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2018
• Distributor Facility Aware Date: 06/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2018
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PHOENIX MACHINE
• Patient Outcome(s): Other
• Patient Weight: 11