MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2794-0

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 10/05/2016

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 reported that the twister on the combiset bloodlines lines came off during hemodialysis treatment which resulted in the patient losing blood.The patient's estimated blood loss (ebl) was noted as being approximately 100ml.The patient care technician installed a new bloodline set, and then the treatment was continued and successfully completed without issue.There were no patient adverse effects experienced and no medical intervention was required as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded at the user facility.However, the user facility has a companion sample which was received by the manufacturer for evaluation.

Manufacturer Narrative

The complaint device was not returned for analysis; however, the user facility provided 22 companion samples from the same lot to the manufacturer for physical evaluation.A visual examination was performed on all returned tubing sets; no defects were identified.One companion sample was then tested using a 2008t hemodialysis machine for simulated use.The bloodline was able to be primed with no visible issues.During the simulated use test, fluid flowed through the lines without issue.There were no observations of a leak or air bubbles and no level variation of the venous or arterial drip chambers was visible to indicate the introduction of air into the blood circuit.The device worked as intended with no noted abnormalities and no defects identified.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported defect of twister separation was not able to be duplicated.Although the evaluation of the companion sample confirmed that the device functioned fully as designed and met specification, a definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual complaint device.Therefore, the complaint has been deemed unconfirmed.

Event Description

A user facility reported that the twister on the combiset bloodlines lines came off during hemodialysis treatment which resulted in the patient losing blood.The patient's estimated blood loss (ebl) was noted as being approximately 100ml.The patient care technician installed a new bloodline set, and then the treatment was continued and successfully completed without issue.There were no patient adverse effects experienced and no medical intervention was required as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded at the user facility.However, the user facility has a companion sample which was received by the manufacturer for evaluation.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 6076084
• MDR Text Key: 59070652
• Report Number: 8030665-2016-00552
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Assistant
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 16ER01012
• Other Device ID Number: 00840861100316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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: 43 YR
• Patient Weight: 91