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 03-2742-9

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

The 2008t operator's manual contains the following user warning: ¿the low venous pressure alarm may not occur with every disconnection or needle dislodgement.Check all bloodlines for leaks after the treatment has started.Keep access sites uncovered and monitored.Improper bloodline connections or needle dislodgements can results in excessive blood loss, serious injury, and death.Machine alarms may not occur in every blood loss situation.¿ the plant investigation is in process.A supplemental medwatch report will be submitted upon the completion of this activity.

Event Description

A biomedical technician at the user facility reported a product problem to technical support that occurred approximately forty-five (45) minutes after the patient's hemodialysis (hd) treatment was initiated.The biomed revealed that the venous transducer of the bloodline disconnected from the venous port on the level detector.The treatment was discontinued, and the patient was discharged home.The patient's estimated blood loss (ebl) was noted as being approximately 150 milliliters (ml).Follow-up was provided by the patient's hd nurse who confirmed that blood tests were performed, and no transfusion or hospitalization was required.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient has successfully completed all subsequent hd treatments without issue.Following the event, the machine was pulled from service for evaluation.However, the system repair status is not known.The bloodline was available to be returned to the manufacturer for evaluation.Although the complaint device has been requested, it has not been received.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical examination.The lot number was not provided and could not be determined since the bloodline packaging was not received.A visual inspection of the returned device found the tubing set to be acceptable when assessed to its bill of materials (bom).No cracks were visible and no damage was identified on the venous transducer protector.All bonds from the arterial and venous lines were reviewed and were found to be properly assembled.A dimensional analysis was performed; the venous transducer protector was within specification.A leak test was performed by pressurizing the arterial and venous lines with air to 15 psi for a period of ten minutes.The bloodline was submerged in water for the duration of the test; no leaks were observed.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products from the reported catalog number (03-2742-9) shipped to this account within the selected time frame.A records review was performed on all lots identified.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 lots passed all release criteria.The investigation was not able to identify any device issues that could be associated with the reported event.The evaluation of the complaint device confirmed that the fresenius combi set functioned fully as designed and met specification.Therefore, the complaint has been deemed not confirmed.

Event Description

Follow-up was provided by the biomedical technician who revealed the following.Functional testing performed by the biomed confirmed the system was operating properly.No machine issues were identified.The biomed reported that the bloodline transducer was not properly fitted to the machine and subsequently disconnected.The unit has been returned to service at the user facility without a recurrence of the event as reported.

• 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: 6594019
• MDR Text Key: 76147937
• Report Number: 8030665-2017-00280
• Device Sequence Number: 1
• Product Code: FJK
• 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,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

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: Nurse
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 80 YR
• Patient Weight: 65