MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. PATIENT CONNECTOR CLIP (NON-STERILE); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number	PATIENT CONNECTOR CLIP
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A temporal association with the adverse events of the patients¿ blood loss of 400-600 ml with a resulting drop in hemoglobin level, emergency room visit and the fresenius blood line and hemosafe clip exist.The details surrounding the event as well as the details of the hd treatment is unknown.Reportedly, a hemosafe clip was placed on the venous line.However, it is unknown what make of catheter was utilized and if it was compatible with the hemosafe clip.The adverse event of blood loss is a direct result of the patients¿ dialysis blood line and the central venous line becoming unsecure during hd treatment.A supplemental report will be submitted upon completion of the plant¿s investigation.
Event or Problem Description
A hemodialysis (hd) nurse reported that a blood leak occurred between a fresenius bloodline (combi set) and a central venous catheter (manufacturer unknown) secured with a hemosafe clip (bloodline connector).Reportedly although the hemosafe clip was in place the bloodline was not secure with the venous end of the central venous catheter.During a follow up call to the hd nurse on 8/feb/2018 it was learned that an unidentified patient experienced a 400-600 ml blood loss during a hd treatment (details surrounding treatment are unknown) as a result of a leak at the blood line and central venous line connection.It was reported that the leak may have occurred as the result of the lines being mis-treaded.The hd treatment was stopped, and all lines were discarded.The patient was administered saline and oxygen (amounts and details unknown) and sent to the emergency room (mode of transportation unknown).Reportedly, the patient had a 2 point drop in hemoglobin but, did not receive a blood transfusion.The patient was released from the emergency room within a couple of hours.The hospital course is unknown.The patient did not require any additional hd treatments and hd treatment has resumed.
Additional Manufacturer Narrative
The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.All companion samples have been sold and distributed.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
".".

• Brand Name: PATIENT CONNECTOR CLIP (NON-STERILE)
• Common Device Name: 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: 7299065
• Report Number: 8030665-2018-00305
• Device Sequence Number: 13765699
• Product Code: FJK
• UDI-Device Identifier: 00840861100828
• UDI-Public: 00840861100828
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K001873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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
• Operator of Device: Health Professional
• Device Model Number: PATIENT CONNECTOR CLIP
• Device Catalogue Number: 04-9100-1
• Device Lot Number: 16KR06012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention