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 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The facility administrator (fa) of the user facility reported a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed by the nursing staff.There was no defect or damage seen on the combiset and there were no loose connections made during treatment setup.The patient¿s estimated blood loss (ebl) was approximately 30 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device is 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-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.

Event Description

The facility administrator (fa) of the user facility reported a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed by the nursing staff.There was no defect or damage seen on the combiset and there were no loose connections made during treatment setup.The patient¿s estimated blood loss (ebl) was approximately 30 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device is available to be returned to the manufacturer for physical 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: 12712698
• MDR Text Key: 279020722
• Report Number: 8030665-2021-01654
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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 Expiration Date: 05/31/2022
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 19ER01085
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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; FRESENIUS 2008K MACHINE
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 71 KG