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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss Of Pulse (2562)

Event Type  Injury  

Event Description

Imp ref #(b)(4).

Manufacturer Narrative

Add'l mfr narrative: the blood tubing set involved in this incident was not available for investigation and the lot number could not be provided by the facility.

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS S.A. DE C.V.; 10014 pacifico blvd.; parque industrial pacifico; tijuana, bcn ; MX
• Manufacturer Contact: ramon ruiz ; blvd pacifico no 10014; tijuana ; MX ; 646266700
• MDR Report Key: 4297188
• MDR Text Key: 5190442
• Report Number: 8030638-2014-00013
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Distributor Facility Aware Date: 10/17/2014
• Event Location: Other
• Date Report to Manufacturer: 10/17/2014
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1