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 Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility nurse reported that the venous chamber would not hold prime at the start of a patient¿s hemodialysis (hd) treatment, allowing air to enter the bloodlines.Prior to the start of hd treatment, the fluid in the venous chamber was dropping, so the nurse filled the lines with saline during priming.When the patient¿s blood was in the venous chamber, it was reported that the blood dropped so low, air had entered the bloodlines.There was no machine alarm.The nurse removed the venous bloodline section and replaced it with another venous line from the same lot number.The nurse stated that the same thing happened where the blood dropped below level, allowing air to enter in the bloodline.The patient¿s blood was not returned from both sets of venous bloodlines and the total estimated blood loss (ebl) was noted as more than 200 ml.The patient completed treatment with a set-up of new supplies on a different machine.No patient adverse effects or injuries were experienced, and no medical intervention was required.The patient was able to complete treatment without any further interruptions or complications.The patient¿s hemoglobin was tested after treatment as the patient had a low hemoglobin level prior to the start of treatment, however, no actions were taken regarding the blood loss.The patient continues regularly scheduled hd treatments without issue.The machine was removed from service following the event.The user facility biomedical engineer (biomed) evaluated the machine and confirmed it was functioning properly.The machine was still sequestered pending clinical approval prior to putting back into service.There was no reported defect or crack with either set of bloodlines used.The bloodline device was stated to be available to be returned to the manufacturer for evaluation.This submission documents the reported blood loss from the first set of bloodlines used during the patient¿s treatment.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.The manufacturer received one full set of bloodlines and one venous bloodline.A visual inspection was performed on both samples and no issues or defects were found.The samples were tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a leak or air bubbles.The devices worked as intended with no noted abnormalities.A records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.The investigation into the cause of the problem was not able to confirm the reported event.The testing of the returned samples could not reveal a probable cause for the customer complaint.Therefore, the complaint is not 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: 7240532
• MDR Text Key: 99241931
• Report Number: 8030665-2018-00192
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17KR01109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 76