MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

Patient Problem Blood Loss (2597)

Event Date 02/17/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility clinic manager (cm) reported a blood leak of a hemodialysis (hd) patient caused when nurse attached the venous lumen of an ultrastream perm catheter to the hd lines.The cm reported it cross threaded and caused the leak.The blood leak was noted 42 minutes after hd treatment was initiated.The hd patient did not complete her remaining treatment and was sent to the hospital for evaluation, but was not admitted or transfused.No defect/damage was observed to the catheter or bloodlines.The patient's estimated blood loss (ebl) was between 500-600 ml.It was unknown how the cross-threading occurred.The patient was able to continue with hemodialysis therapy without further issue.The sample was discarded.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the nine lots reported to be present at the facility at the time of the event.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 7364807
• MDR Text Key: 103531418
• Report Number: 8030665-2018-00426
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARGON ULTRASTREAM PERM CATHETER; FRESENIUS 2008K HEMODIALYSIS MACHINE
• Patient Age: 74 YR
• Patient Weight: 42