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

Catalog Number 101025

Device Problem Crack (1135)

Patient Problem Blood Loss (2597)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

During the last few minutes of a dialysis treatment, there was an external blood leak on the blood tubing set.Treatment was stopped and the blood in the extracorporeal circuit was not returned to the patient.The blood loss to the patient was estimated to be between 338 ml - 438 ml.The patient was not symptomatic and did not require any medical intervention.The patient was discharged home following this event.

Manufacturer Narrative

The blood tubing set received shows cut tubing at the pump segment resulting from an excess amount of glue and stress applied during the assembly process.15 retained samples from same lot number reported 1000079625 were analyzed.No deviation or anomaly was identified.The 15 retained samples were found conforming to manufacturer specifications.No other complaints were reported for this lot number.This was an isolated event.

• 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.; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX
• Manufacturer Contact: ramon ruiz ; blvd. pacifico no. 10014; parque industrial pacifico; tijuana ; MX ; 6646266700
• MDR Report Key: 3848529
• MDR Text Key: 4659806
• Report Number: 8030638-2014-00008
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2014,06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Catalogue Number: 101025
• Device Lot Number: 1000079625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Report Sent to FDA: 06/06/2014
• Distributor Facility Aware Date: 06/03/2014
• Device Age: 4 MO
• Event Location: Dialysis Unit
• Date Report to Manufacturer: 05/09/2014
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHOENIX SN (B)(4), SWV 3.36.02, REVACLEAR
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 68