MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HEMOCONCENTRATOR; DIALYZER, HIGH PERMEABILITY

Catalog Number ZZ*HC11S

Device Problem Complete Blockage (1094)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device has not been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and shipping inspection record of the involved product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported clogging in the capiox device during a procedure.Follow up information provided by the user facility reported the following: the hemoconcentrator was built into a custom pack adult cx-be092x, lot 1608291; bypass was started with the custom pack; filtering with the hemoconcentrator was started without problem; the perfusionist closed the clamp of the hemoconcentrator for giving the cardioplegia; the moment that the clamp was opened to restart the filtering, it was noticed that the hemoconcentrator was obstructed; no flow could pass through the device; the perfusionist remove the hemoconcentrator and exchange with another device; the surgeon did not experience any problem or delay due to the issue; the only lost blood was the blood in the partly filled hemoconcentrator; and the patient was not harmed.

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no obvious anomalies.The actual sample was rinsed and another visual inspection focusing on the state of the fiber was conducted.No anomalies were noted.The actual sample was built into a circuit.Bovine blood was let to flow through the tubes.It was confirmed, an adequate blood flow rate was achieved.The pressure loss was determined while bovine blood was circulated in the circuit at the flow rate of 500ml/min.And tmp400mmhg.The obtained values were confirmed to meet manufacturing specification.No anomalies or no obstruction was confirmed.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the actual sample was normal product with no issue in the gas transfer performance.While the exact cause of the reported event cannot be definitively determined based on the available information, clots may have formed inside the fiber preventing blood from flowing in the normal manner.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: the capiox hemoconcentrator is designed to operate at flow rate within the range of 100 to 500ml/min during ultrafiltration.Do not use blood flow rates outside this range.Less than 100ml/min blood flow may cause blood coagulation in the device.Do not exceed 50% hematocrit at the blood outlet during ultrafiltration.Do not stop blood flow during extracorporeal circulation as it may cause clotting in the system.A blood flow of least 50ml/min is recommended even if ultrafiltration is stopped by clamping the filtrate line.Bubbles in the system may cause clotting and blood damage.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX HEMOCONCENTRATOR
• Type of Device: DIALYZER, HIGH PERMEABILITY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6685325
• MDR Text Key: 79066461
• Report Number: 9681834-2017-00131
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K973516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2017

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: 03/31/2019
• Device Catalogue Number: ZZ*HC11S
• Device Lot Number: 160426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/04/2017
• Supplement Dates Manufacturer Received: 07/05/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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
• Patient Age: 76 YR
• Patient Weight: 95