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 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  a temporal relationship exists between hemodialysis (hd) therapy utilizing the custom combi set and the patient¿s serious adverse events of blood loss (ebl 500 ml) which warranted hospitalization.Per the clinical manager (cm), the cause of the blood leak is unknown; therefore, causality cannot be determined.Additionally, the custom combi set was discarded following the events, making a physical examination of the product not possible.Based on the totality of the information available, there is insufficient evidence to exclude the custom combi set from having a possible causal or contributory role in the events.Given the lack of discharge summary, manufacturer evaluation of the product and/or treatment data; there is insufficient evidence to disassociate the custom combi set from these events.

Event Description

A user facility clinical manager reported a blood leak from underneath treatment chair to the floor while the fresenius combiset bloodlines were in use.A fresenius dialyzer and patient¿s central venous catheter (cvc) lumen were connected at the time.The blood leak was noticed approximately past midway into the patient¿s hemodialysis (hd) treatment.Patient catheter has been tested and is intact.Physical assessment showed dialysis lines properly secured to catheter-hemo clip in place.The clinical manager reported that the cause of the leak was unknown.The patient¿s treatment was discontinued, a saline and blood bolus administered (amount administered unknown), and sent to the hospital for evaluation.The patient's estimated blood loss (ebl) was approximately 500 ml.Per the clinical manager, the patient was admitted to the hospital.Additional details regarding the patient¿s hospital visit were requested, however, were unknown.Additional details regarding the reported event, including treatment records, were requested but not provided.The manufacturer of the patient's cvc was unknown.It was confirmed that the complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.

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-conformance's 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
• 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: 8975009
• MDR Text Key: 156911692
• Report Number: 8030665-2019-01423
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: 09/18/2019

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: 04/30/2022
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 19DR01105
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 75