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 Occlusion Within Device (1423)

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

Event Date 06/14/2017

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 labeling, 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

The patient care technician (pct) at the user facility reported that the arterial chamber of the combi set bloodline clotted off while a patient underwent their hemodialysis (hd) treatment.No allegation of patient adverse effects being experienced as a result of this incident.Although follow-up was requested, no additional details have been provided.

Event Description

A user facility¿s curse manager reported that a blood leak occurred on the combi set bloodlines approximately two (2) hours after initiation of the patient¿s hemodialysis (hd) treatment.The patient has been undergoing hd therapy three (3) times per week for five (5) years.No damage or defects were visible to the bloodline or its packaging.The patient was disconnected from the machine, the lines were put into recirculation, the transducers were replaced, saline was run through the lines, and the lines were replaced after clotting in the arterial chamber was noted.The blood within the extracorporeal circuit was not returned.The patient¿s estimated blood loss was approximately 300 milliliters (ml).The patient was re-setup with a new dialyzer and bloodline on the same machine, and then the hd therapy was continued and successfully completed without any issues.The hd machine generated a trans-membrane pressure (tmp) alarm.The patient was on heparin.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The combi set bloodlines were not available to be returned to the manufacturer for 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.; 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: 6713094
• MDR Text Key: 80058735
• Report Number: 8030665-2017-00442
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17BR01231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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: 73 YR
• Patient Weight: 77