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 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300 ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.The sample was reported to have been available to be returned for evaluation.

Manufacturer Narrative

Corrected expiration date: 2020-08-31 corrected occupation: health care professional plant investigation: complaint sample is not available for evaluation to confirm the alleged product malfunction.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the reported complaint.The lot passed all release criteria.

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.The sample was reported to have been available to be returned for evaluation.

Manufacturer Narrative

Common device name: set, tubing, blood, with and without anti-regurgitation valve.Fda product code: fjk - set, tubing, blood, with and without anti-regurgitation valve.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.The sample was reported to have been available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: one sample was received from the customer without original package or identified.During the evaluation of the actual sample the alleged failure was not confirmed in the stated complaint.The visual inspection and functional test passed.During the period tested no air bubbles inside the system, no leaks and no level variation of venous and arterial chamber or any alarm were noted.The sample tested worked as intended without any abnormalities during the tested period.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the reported complaint.The lot passed all release criteria.

Event Description

A hemodialysis (hd) patient's clinic biomedical engineer (biomed tech) reported during hd treatment the technician noticed air in blood line approximately one minute into treatment.No alarm was noted.The air was noted to have passed the occlusion clamp around the needle area.No external leaks were noted.The patient was removed from machine and blood was not returned to patient.The patient's blood loss was 300ml.The hd patient was unable to complete hd treatment, was sent to the emergency room, evaluated and released.The patient returned to the clinic the following day per doctor's order and completed hd treatment the following day.The on-call physician requested the machine to have air detector recalibrated and an occlusion test was performed and completed.The sample was reported to have been available to be returned 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: 7082591
• MDR Text Key: 94640669
• Report Number: 8030665-2017-01069
• 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,Followup,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 17KR01196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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: 26 YR
• Patient Weight: 90