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

Model Number 03-2621-5

Device Problem Fluid/Blood Leak (1250)

Patient Problems Anemia (1706); Chest Pain (1776); Dyspnea (1816); Weakness (2145)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between the patient¿s hemodialysis treatment utilizing the custom combi set and blood loss with drop in hemoglobin requiring two units of prbc to be transfused.Additionally, there is a causal relationship between the adverse event and the reported puncture holes in the venous tubing leading to patient blood loss.The tubing was disposed of and not returned for evaluation, but the allegation of the tubing punctures is supported by the report of the patient blood loss with transfusion due to anemia (drop in hgb 9.6 to 7.8) any significant change in hgb values is dangerous for dialysis patients.Hemoglobin concentrations are associated with an increased risk of morbidity and mortality in chronic kidney disease.Although no leak was noted prior to start of treatment, the manual for the hemodialysis machine states to check the bloodlines for leaks once treatment has been initiated.Based on the available information, the venous tubing blood leak caused the patient¿s significant drop in hemoglobin requiring administration of two units of prbc.

Event Description

A hemodialysis (hd) outpatient clinic reported that a blood leak occurred an hour and fifteen minutes into a patient¿s hd treatment on (b)(6) 2019.The staff noticed blood leaking from behind the patient¿s chair.The leak was reportedly coming from a hole in the venous line of the combi set.The patient¿s estimated blood loss (ebl) was 500 ml.After the blood leak was discovered, the treatment was ended, the blood was cleaned up, and the patient was transferred to a new machine with stable vital signs.After completing treatment on the new machine, the patient was discharged in stable condition.The patient and their spouse were educated on signs of anemia and instructed to go to the emergency room (er) should any signs/symptoms appear.On (b)(6) 2019 the patient experienced chest pain and shortness of breath.The patient went to the er and was put under observation.The patient¿s hemoglobin (hgb) on arrival to the er was 7.8 which was a drop from the (b)(6) when it was 9.6.The patient received two units of packed red blood cells (prbc) and was discharged to their home on (b)(6) 2019 with a hgb of 8.7.The patient returned to the hd clinic on (b)(6) 2019 and has been continuing treatment without any further issues.Upon follow up with the user facility, it was reported that the hole in the venous tubing looked like a ¿snake bite (two fang punctures)¿ [sic].Reportedly, the staff has inspected all subsequent bloodlines from the lot, and nothing else has been found.The complaint device was not available to be returned for physical evaluation as it was reportedly discarded.

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.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.

• Brand Name: CUSTOM COMBI SET W/SPLIT SEPTUM
• 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: 9594306
• MDR Text Key: 178352261
• Report Number: 8030665-2020-00066
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100224
• UDI-Public: 00840861100224
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 03-2621-5
• Device Catalogue Number: 03-2621-5
• Device Lot Number: 19KR01001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR