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 Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.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 material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

Event Description

A user facility biomedical technician reported that a 2008t hemodialysis (hd) machine failed to generate audible and/or visual alarms despite the presence of blood clots in both the venous and arterial lines.Most of the blood within the extracorporeal circuit was returned, and then the patient was re-setup on another machine.The patient was able to continue and successfully complete the hd therapy with no further issues being reported.The patient¿s estimated blood loss (ebl) was noted as being approximately 50 milliliters (ml).At the time of the event, heparin was in use and was being delivered properly.The biomed indicated that the bloodlines kept slipping out of the blood pump due to the rotor being loose.Reportedly, the staff experienced difficult loading the bloodlines prior to treatment initiation, and had to periodically realign the lines during the treatment.No patient adverse effects were experienced and no medical intervention was required as a result of this event.Following the event, the 2008t hd machine was removed from service for evaluation.The biomed replaced the blood pump rotor to resolve the loose rotor issue.The biomed stated that the loose rotor likely caused the machine to not produce audible or visual alarms.The unit has been returned to service at the user facility without a recurrence of the event as reported.No parts from the 2008t hd machine were available to be returned to the manufacturer for physical examination.The bloodline was not available to be returned to the manufacturer for analysis as it was discarded by the user facility.

• 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: 6541634
• MDR Text Key: 74414712
• Report Number: 8030665-2017-00220
• 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
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 16JR01018
• Other Device ID Number: 00840861100316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2016
• 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