MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LOW VOLUME PRE-PUMP BLOODLINE (12/CS); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number	LOW VOLUME PRE-PUMP BLOODLINE
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A nurse manager at a user facility reported that the heparin line was obstructed and that during treatment the heparin is unable to be infused.Consequently, patient¿s blood ended up clotting within five minutes remaining in treatment.Patient¿s estimated blood loss was approximately 200 ml.The machine, a fresenius 2008k2 machine, did alarm appropriately with heparin pump alarm.Additionally, the nurse manager reported that treatment was no completed; however, reported that the patient has been able to complete regularly schedule hemodialysis (hd) treatments since the event.The complaint device is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Plant investigation: the manufacturing plant received an actual sample of product 03-2692-6 lot number 17lr01286 from customer.A visual inspection was performed and an obstruction was noticed inside of heparin line.A functional test was performed to actual sample in order confirmed the alleged failure.A solution was introduced inside of heparin line and was confirmed the occlusion.
Event or Problem Description
".".

• Brand Name: LOW VOLUME PRE-PUMP BLOODLINE (12/CS)
• 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: 7548366
• Report Number: 8030665-2018-00792
• Device Sequence Number: 284505
• Product Code: FJK
• UDI-Device Identifier: 00840861100262
• UDI-Public: 00840861100262
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K001107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: LOW VOLUME PRE-PUMP BLOODLINE
• Device Catalogue Number: 03-2692-6
• Device Lot Number: 17LR01286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Device Age: MO
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 07/23/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/06/2018; 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008K2