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 03-2742-9

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypovolemia (2243)

Event Date 02/17/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal association between the adverse event(s) of the patient¿s blood loss, medical evaluation, and the custom combiset exists.However, there is no documentation or evidence of any defect at the connection site of the blood line to the catheter, nor was there any other blood line issues leading up to the event that could have caused the loose connection.The exact cause of the catheter and blood line becoming unsecured 45 min after the initiation of hemodialysis (hd) therapy is unknown.However, based on the statement made by the clinical manager, it is suspected the connection was not properly tightened.Additionally, there is no documentation to state if the patient¿s access site was uncovered.The adverse event(s) were a direct result of the patient¿s dialysis blood line becoming unsecure and leading to the blood loss and subsequent need for medical evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A user facility clinical manager reported a blood leak between the combiset bloodlines and the patient¿s central venous catheter (cvc) lumen.The blood leak was noticed approximately 45 minutes into the patient¿s hemodialysis (hd) treatment.The clinical manager reported that the leak was due to a loose connection and suspects that it was not tightened properly.The patient¿s treatment was discontinued, saline bolus administered (amount administered unknown), and sent to the hospital for evaluation.The clinical manager reported that the patient is blind and was wearing a large coat on the day of the event, which was absorbing the blood.The patient's estimated blood loss (ebl) was approximately 600 ml.Per the clinical manager, the patient was not admitted to the hospital and was sent home later that day.Additional details regarding the patient¿s hospital visit and treatment course are unknown.Per the clinical manager, the patient has since continued hemodialysis treatment with no further issues and without reoccurrence of the reported event.Additional details regarding the reported event were not provided.The lot number of the complaint device was unknown.Additionally, the central venous catheter is a non-fresenius device and manufacturer information is unknown.It was confirmed that the combiset was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7348629
• MDR Text Key: 102737538
• Report Number: 8030665-2018-00397
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K MACHINE; UNKNOWN FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 42