MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM ROLLER PUMP - 8INCH

Model Number QRP8

Device Problems Defective Component (2292); Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

Review of the photographic evidence, showed dried organic matter (since cleaned, but presumed to be dried blood) running in a horizontal thin line around one of the rollers, we do not have enough evidence to know exactly how long that organic matter had been present, but from the photographs we can see that it was most likely to have been present before the second tube was inserted and would certainly contribute to the very quick degradation of the second tubing set installed.We have found nothing significant with the product to suggest it was faulty equipment.

Event Description

Tubing rupture on arterial roller during pediatric case.Perfusionist changed out raceway and placed new raceway into roller.After approximately 10 minutes the new tubing could be seen wearing away in the raceway.Roller pump subsequently changed out.Looking at roller pump pictures there appears to be a defect in one of the rollers at the base which is circled in black.

Manufacturer Narrative

No root cause found.

Event Description

Tubing rupture on arterial roller during pediatric case.Perfusionist changed out raceway and placed new raceway into roller.After approximately 10 minutes the new tubing could be seen wearing away in the raceway.Roller pump subsequently changed out.Looking at roller pump pictures there appears to be a defect in one of the rollers at the base which is circled in black.

• Brand Name: QUANTUM ROLLER PUMP - 8INCH
• Type of Device: ROLLER PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; harrier 4 meteor business park; cheltenham rd east; gloucester, GL29Q L; UK GL29QL
• Manufacturer Contact: colleen powell ; harrier 4 buiness park; cheltenham rd east; gloucester, GL29Q-L ; UK GL29QL
• MDR Report Key: 14336921
• MDR Text Key: 299879225
• Report Number: 3006073153-2022-00001
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: 05060434420770
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QRP8
• Device Catalogue Number: 51-000008-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 88 KG