MAUDE Adverse Event Report: SANMINA PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 06002-110-EXP-EW

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Haemonetics product support has sent a replacement pump assembly to be installed by the on-site technician.Follow up with the customer revealed that there was no adverse outcome for the donor as a result of the blood migration to the ac bag.The issue of anticoagulant depletion has been investigated under a corrective action, where the results of the investigation determined that the likely cause was harsh cleaning solutions used to clean the pump rollers at the customer site.These chemicals can cause damage to the pump rollers which may lead to a device malfunction.Haemonetics confirmed that the customer is aware of the haemonetics medical device safety alert regarding the proper cleaning solutions to use to prevent the early degradation of the rotors.

Event Description

On (b)(6) 2017 haemonetics was notified via the product support hotline that the customer experienced an ac run out/depletion incident.The customer requested that haemonetics send a replacement pump assembly.Follow up with the customer revealed that there were no adverse donor reactions experienced.The entirety of the anticoagulant solution was not dispensed to the donor, however the customer was concerned because of an observation of blood migrating against the flow up the ac line.The customer reported that prior to this incident the device had alarmed "ac pump wrong direction code 207" on five different occasions.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer (Section G): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer Contact: david ramsay ; 400 wood rd; braintree, MA 02184 ; 7813487327
• MDR Report Key: 6910371
• MDR Text Key: 88251167
• Report Number: 1219343-2017-00026
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/03/2017

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: No Information
• Device Model Number: 06002-110-EXP-EW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1