MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, S.A. DE C.V. CARTRIDGE BLOOD SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 101025

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Event Description

Patient was placed on dialysis machine.Rn charted vitals and pressures.Arterial pressure was reading "0".On review, the arterial side of the set-up was missing the pressure pod.

• Brand Name: CARTRIDGE BLOOD SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, S.A. DE C.V.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12445670
• MDR Text Key: 270586046
• Report Number: 12445670
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

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: No Information
• Device Model Number: 101025
• Device Catalogue Number: 101025
• Device Lot Number: (10)1000289177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 40