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 Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between hd therapy utilizing the custom combi set and the patient¿s serious adverse event of blood loss (ebl 100 ml) which required the initiation of an esa agent.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 event.Given the lack of product available for manufacturer evaluation and/or treatment data; there is insufficient evidence to disassociate the custom combi set from the event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility nurse reported a blood leak from the venous transducer.The patient¿s estimated blood loss was 100 cc.The machine did not alarm.The blood pump was stopped.700 ml of normal saline was administer during treatment.An additional 300 ml of normal saline was administered at the end of treatment.The patient¿s blood pressure (b/p) was reported as 73/45.Upon discharge from the outpatient dialysis unit, the patient was alert and oriented, with stable vital signs.Upon follow up, the patient¿s hemoglobin was 8.8 g/dl following the event, and a hemoglobin result from (b)(6) 2019 was 7.6 g/dl.As such, the patient was started on an erythropoietin stimulating agent (esa) mircera.The current disposition of the patient is unknown.

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
• 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: 9080930
• MDR Text Key: 160667374
• Report Number: 8030665-2019-01481
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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: 19DR01181
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention