MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problem Occlusion Within Device (1423)

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

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A dialysis clinic manager reported a blood clot occurred during hemodialysis (hd) treatment on (b)(6) 2017.The 2008k hd machines generated alarms when hd therapy was first initiated.No external leaks were noted and no damage to the combiset or packaging was observed.Per clinic manager the blood was not returned to the patient and the estimated blood loss (ebl) for each of the patient was unknown.The clinic manager stated no patient adverse effects were experienced and no medical intervention was required as a result of the reported event.The patient dialyzed 3 times a week and was able to complete treatment with new supplies using the same machine without issue, and did not require any medical intervention or additional treatments as a result of the reported occurrence.The sample was discarded and was no longer available for evaluation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

Event Description

A dialysis clinic manager reported a blood clot occurred during hemodialysis (hd) treatment on (b)(6) 2017.The 2008k hd machines generated alarms when hd therapy was first initiated.No external leaks were noted and no damage to the combiset or packaging was observed.Per clinic manager the blood was not returned to the patient and the estimated blood loss (ebl) for each of the patient was unknown.The clinic manager stated no patient adverse effects were experienced and no medical intervention was required as a result of the reported event.The patient dialyzed 3 times a week and was able to complete treatment with new supplies using the same machine without issue, and did not require any medical intervention or additional treatments as a result of the reported occurrence.The sample was discarded and was no longer available for evaluation.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• 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: 6922253
• MDR Text Key: 89937330
• Report Number: 8030665-2017-00807
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17HR01043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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: 51 YR
• Patient Weight: 117