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

Model Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility registered nurse (rn) reported that a combi set blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.When the rn removed the cap on the medication port to add venofer, the entire medication line separated from the venous chamber and blood started leaking out.The rn stopped the blood pump immediately.The rn stated the patient has an iron deficiency and indicated that the addition of venofer during treatment was standard procedure for this patient.When the separation occurred, there were no alarms from the machine.In addition, the rn confirmed there had been no adjustments made to the patient¿s blood flow rate (bfr).The rn confirmed that all connections appeared to be secure during pre-treatment inspection and priming.The rn was unsure what caused the line to separate.They stated it was almost as if the sealant failed.The patient was dialyzing on a fresenius 2008t hd machine and was utilizing an optiflux 180nre dialyzer.The patient¿s blood was not returned.Their estimated blood loss (ebl) was 300 ml.The rn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The sample was reported to be available for a manufacturer evaluation.

Manufacturer Narrative

Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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 the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.

Event Description

A user facility registered nurse (rn) reported that a combi set blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.When the rn removed the cap on the medication port to add venofer, the entire medication line separated from the venous chamber and blood started leaking out.The rn stopped the blood pump immediately.The rn stated the patient has an iron deficiency and indicated that the addition of venofer during treatment was standard procedure for this patient.When the separation occurred, there were no alarms from the machine.In addition, the rn confirmed there had been no adjustments made to the patient¿s blood flow rate (bfr).The rn confirmed that all connections appeared to be secure during pre-treatment inspection and priming.The rn was unsure what caused the line to separate.They stated it was almost as if the sealant failed.The patient was dialyzing on a fresenius 2008t hd machine and was utilizing an optiflux 180nre dialyzer.The patient¿s blood was not returned.Their estimated blood loss (ebl) was 300 ml.The rn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The sample was reported to be available for a manufacturer evaluation.

• 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.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12713694
• MDR Text Key: 279020918
• Report Number: 8030665-2021-01655
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 21HR01101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 95 KG